Reporte zur Charge UJ347ABA

Symptomtext

syringe issue; when reconstituting ACTHIB the needle popped off the syringe and about 1/4 of the diluent spilled from the syringe onto the counter; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 month old male patient who had received a 0.5 mL dose HIB (PRP/T) VACCINE [ACT-HIB] whose needle popped off the syringe while reconstituting and about 1/4 of the diluent spilled from the syringe onto the counter and syringe issue,(lot UJ347ABA and expiry date 30-july-2021) and received via intramuscular route in the right thigh for prophylactic vaccination on 15-Feb-2021(underdose and syringe issue). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and WATER FOR INJECTION (STERILE WATER FOR INJ.). Caller stated that when they drew the vaccine up, they used the package diluent and when they administered the vaccine, the needle popped off and not all of the vaccine was administered because part of it spilled out. this case associated with syringe issue. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.