Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | N733B | — |
the product leaked onto the patient's arm; ENGERIX-B leaked while administering to the patient; full dose was not administered; product leaked; Product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of exposure via skin contact in a male patient who received HBV (Engerix B adult) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced exposure via skin contact (Verbatim: the product leaked onto the patient's arm), accidental exposure while administering drug (Verbatim: ENGERIX-B leaked while administering to the patient), accidental underdose (Verbatim: full dose was not administered), product leakage (Verbatim: product leaked) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the exposure via skin contact, accidental exposure while administering drug, accidental underdose, product leakage and pharmaceutical product complaint were not applicable. Additional Information: GSK Receipt Date: 23-JUN-2025 The nurse reported that one prefilled syringe of Engerix b leaked while administering to the patient. Because of this, the product leaked onto the patient's arm and the full dose was not administered which led to accidental underdose. It was confirmed that luer lock needle was used.