Reporte zur Charge U036507

Symptomtext

No other adverse events reported.; Sterile Injectable;Broken During or After injection;Broken Syringe; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; This spontaneous report was received from a registered nurse referring to a child with unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. Nurse reporting that on Tuesday 14-JUN-2022 that a pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) syringe broke during the administration to a patient. Nurse reported that while the needle was in the child and then while she was engaging the plunger, the glass on the syringe broke, clarified as near the rim, it broke into pieces. Caller reported she believed it was the finger flange area that broke. Caller reported that the plunger could not be engaged after it broke and therefore the patient had to be stuck a second time to be given the medication (from same tray, with same lot/exp). Caller had set the product aside for retrieval and attempt to provide pictures via email. No further information provided. No other adverse events reported. No product quality complaint. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes: o 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. o 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). o Please provide a detailed description of the defect using the questions below: o Is there a crack? NO o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) FINGER FLANGE PIECE, SHATTERED OFF o Provide the exact location of the breakage on the syringe? CALLER STATES THE RIM, BELIEVES TO BE FINGER FLANGE PIECE. o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. SEE ABOVE o Provide the exact location of the breakage on the syringe? SEE ABOVE o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? NO (if yes describe) o Was there difficulty trying to attach the syringe needle to the syringe? NO o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used? NA o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? NA o Is there any broken glass or other separated component in the tray? (if yes specify) NA o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? NO o While giving the injection? YES o Immediately after giving the injection? NO o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: NA o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. NA o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage NA o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) YES o If yes, describe NA o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES o If complaint sample is not/cannot be returned, please provide reason: WILL ATTEMPT TO RETURN *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) o 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: Repeat User Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 16-JUN-2022 17:30 PM :Attachment added. 16-JUN-2022 17:30 PM :Attachment added. 16-JUN-2022 17:30 PM :*Correction- No other adverse events or product quality complaints reported. 16-JUN-2022 17:30 PM :Attachment added. 16-JUN-2022 17:30 PM :Email received on 16-JUN-2022 at 3:20pm with pictures related to this case. See attached. 16-JUN-2022 17:30 PM :Waiting for retrieval--See attachments 16-JUN-2022 17:30 PM :Attachment added. 16-JUN-2022: - PHOTOS received & attached. 16-JUN-2022: Second person review 17-JUN-2022 10:30 AM :Attachment added. 17-JUN-2022 12:30 PM :Labels created 21-JUN-2022 Agent attempted outbound call to the customer but office was closed, will make another attempt to reach customer on 22-JUN-2022 to follow-up on return of product. 21-JUN-2022 Correction to previous note-- will make an attempt on 23-JUN-2022. 24-JUN-2022 Customer follow-up #1: agent made outbound call to the customer in an attempt to follow-up on the status of return of product. Agent was able to speak to the customer and she was unaware that return package had been delivered. Customer was provided delivery tracking information and placed agent on hold to verify and then confirmed receipt and stated she will send the product back today. No further information provided.