Symptomtext
No additional adverse events reported; Nurse reports that GARDASIL 9 was administered to a patient where product squirted in the Patient's face.; it was noticed that the administered GARDASIL 9 had a pin size hole located in the luer lock tip cap/Nurse found one more prefilled syringe with the same size hole and in the same location that was not administered.; apin size hole located in the luer lock tip cap; broken syringe barrel; cracked or broken luer lock; This spontaneous report was received from a registered nurse, referring to a male patient of unknown age. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported. On 02-MAY-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U028826, expiration date reported and validated as 04-NOV-2023) as prophylaxis. On 02-MAY-2022, a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to a patient where product squirted in the patient's face (accidental exposure to product). Nurse reported that upon investigation, it was noticed that the administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had a pin size hole located in the luer lock tip cap. Nurse reported that she investigated the rest of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and found one more prefilled syringe with the same size hole and in the same location that was not administered (syringe issue and product primary packaging issue). No additional adverse events reported. Nurse reporting a product quality complaint and adverse event pertaining to GARDASIL 9. Nurse reports that GARDASIL 9 was administered to a patient where product squirted in the Patient's face. Nurse reports that upon investigation, it was noticed that the administered GARDASIL 9 had a pin size hole located in the luer lock tip cap. Nurse reports that she investigated the rest of the GARDASIL 9 and found one more prefilled syringe with the same size hole and in the same location that was not administered. Nurse did not want to provide any Patient information. Nurse stated that Patient was okay and the Provider was going to take care of it in house. No additional adverse events reported. QUESTION SECTION: Medium Risk: Broken Syringe Barrel. High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). Please provide a detailed description of the defect using the questions below: Is there a crack? No o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: Is the syringe broken into 2 or more pieces? No o If yes, describe in detail how it is broken: (e.g., shattered, broken in half etc.) o Provide the exact location of the breakage on the syringe? o Does the syringe have a broken component? No (e. g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes describe in detail how it is broken. o Provide the exact location of the breakage on the syringe? o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/ UNSPECIFIED (if yes describe). o Was there difficulty trying to attach the syringe needle to the syringe? No o If yes, describe o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED. o If not supplied by MERCK, what type & brand, needle size & gauge was used? Under what situation was this defect noticed: (select one) 1: administered: 2: upon investigation of all products o While the syringe was still in the tray? Yes, #2 o If yes, is there product (liquid or dried residue) in the tray? No o Is there any broken glass or other separated component in the tray? (if yes specify) No o After removing the syringe from the tray? No While trying to attach the needle to the syringe? No o While giving the injection? Yes, #1 o Immediately after giving the injection? No Was the syringe tip cap attached properly prior to use? Yes o If no, describe issue: Was the syringe tray intact and undamaged on receipt? Yes o If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? oSee below. Yes o If no, describe damage Was the syringe carton damaged prior to use? (i.e., crushed, ripped, unglued) No o If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e., biohazardous)? Yes If complaint sample is not/cannot be returned, please provide reason: *If photos are available, ask the customer to send them Retrieval Information: Obtain product (& tray if possible) Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Unknown Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 06-MAY-2022: Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 06-may-2022: tip cap that was removed a photo of the syringe thank you. Notification; 1102160767 06-MAY-2022 14:30 PM: Email received in the PQC mailbox on 06-MAY-2022 at 1:09pm with the following request from quality: "Please clarify if the hole was in part of the tip cap that was removed or in the plastic Luer Lock piece that the needle is screwed onto. Please request a photo of the syringe and request the syringe that was not administered to be returned if available. " 09-MAY-2022 12:30 PM: Nurse reported that she looked up the parts of the syringe and stated that hole was in the luer lock location of syringe. Nurse reported that she will attempt to send pictures if possible due to how small the hole is. Agent provided Nurse with email address listed in PQC questionnaire to submit pictures. Nurse reports that she will return both syringes, the one that was administered, as well as, the non-administered syringe that she found in the box. No further details provided. 09-MAY-2022: Attached f/u: Email received in PQC mailbox on 05-MAY-2022 at 3:36pm from Quality: "Also please ask if the syringe that was administered is available for return in addition to the one that was not administered." Forwarded to case owner for follow up.