Received Nov 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9G523 | — |
Cut; Plunger broke when the plunger was depressed; Product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of skin laceration in a female patient who received HBV (Engerix B Junior) (batch number 9G523, expiry date 20-MAY-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Engerix B Junior .5 ml. On an unknown date, an unknown time after receiving Engerix B Junior, the patient experienced skin laceration (Verbatim: Cut), device breakage (Verbatim: Plunger broke when the plunger was depressed) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the skin laceration was unknown and the outcome of the device breakage and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the skin laceration and device breakage to be related to Engerix B Junior and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the skin laceration and device breakage to be related to Engerix B Junior and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-NOV-2025 The reporter stated that during preparation for administration the bottom of the plunger broke when the plunger was depressed to prime the syringe (injection - 0160 - broken). The reporter preparing the PFS for administration was cut when the bottom of the plunger broke off. The box was thrown away. The product was still present in the syringe. The crack/breakage observed on the very bottom of the plunger ROD. This prefilled syringe was not used to administer a dose of vaccine, however, the vaccine was administered using a different Enegrix-B PFS. No further information was provided