Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2R3BY | — |
glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off; Product Complaint; needle stuck; not all the liquid not all the vaccine went in to the patient's leg"; This non-serious case was reported by a nurse via call center representative and described the occurrence of needle stick/puncture in a 8-month-old female patient who received Hib (Hiberix) (batch number 34L24) and (batch number 2R3BY, expiry date 15-JUL-2026) for prophylaxis. This case was associated with a product complaint. On 04-MAR-2025, the patient received Hiberix. On 04-MAR-2025, an unknown time after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: needle stuck) and incomplete dose administered (Verbatim: not all the liquid not all the vaccine went in to the patient's leg"). On an unknown date, the patient experienced device connection loose (Verbatim: glass little part that you screw in the needle tto, that little glass part is loose/syringe popped off) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the needle stick/puncture was not reported and the outcome of the incomplete dose administered, device connection loose and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the needle stick/puncture and device connection loose to be related to Hiberix. It was unknown if the company considered the needle stick/puncture and device connection loose to be related to Hiberix. Additional Information: GSK Receipt Date: 04-MAR-2025 The nurse reported that in the prefilled syringe in the glass little part that you screw in the needle too, that little glass part was loose. So the nurse was assuming that when she put the pressure it went through and it popped-off in that part, she when she was injecting it with the pressure of the injection popped it off and not all the liquid not all the vaccine went in to the patient's leg. The nurse reported that once the Hiberix was mixed and the needle was placed in the patient's left leg the syringe popped off and the needle stuck in the babies left leg. The defect was discovered during administration. The product was only partially administered which led to incomplete dose adminstred. Syringe was involved in the complaint. There was no defect or damage on the syringe noticed. When removing the cap, it was screwed off.