Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | KF25B | RL |
needle stayed in the patient's leg; steps were not done correctly; patient received partial dose due to the needle coming off of syringe during administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental needle stick in a 6-month-old male patient who received Hib (Hiberix) (batch number KF25B, expiry date 14-JUL-2026) for prophylaxis. On 03-FEB-2025, the patient received the 3rd dose of Hiberix (injection, right thigh). On 03-FEB-2025, an unknown time after receiving Hiberix, the patient experienced incomplete dose administered (Verbatim: patient received partial dose due to the needle coming off of syringe during administration). On an unknown date, the patient experienced accidental needle stick (Verbatim: needle stayed in the patient's leg) and wrong technique in device usage process (Verbatim: steps were not done correctly). The outcome of the accidental needle stick was not reported and the outcome of the incomplete dose administered and wrong technique in device usage process were unknown. It was unknown if the reporter considered the accidental needle stick to be related to Hiberix. It was unknown if the company considered the accidental needle stick to be related to Hiberix. Additional Information: GSK Receipt Date: 07-FEB-2025 The nurse reported that the product quality complaint ruled out due to incorrect preparation. While reviewing product instructions for use step by step, reporter states that the steps were not done correctly. Instructions for vial and prefilled syringe presentation figure one was align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotate a quarter turn clockwise until you feel it lock, was not performed as per package inset. Facility nurses were not gently connecting the needle hub into the Luer Lock Adaptor (LLA) and rotating a quarter turn clockwise until they feel it lock. Reporter states that patient received partial dose due to the needle coming off of syringe during administration, which led to incomplete dose administered. When nurse attempted to take needle out of patients right upper thigh the needle stayed in the patient's leg. Reporter states that the child's health care professional provider evaluated the partial dose given and determined that enough of the dose was administered and the dose did not need to be repeated. This case is linked with US2025016605, reported by same reporter.; Sender's Comments: US-GSK-US2025016605:Same reporter/Diffrent patient