Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Y009551 | OT |
No additional AE; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; 1 of 10 vaccine syringes tip/leur lock was broken; leaked out of a hole at the top of the syringe where the break occurred on her hand but did not report any other adverse issues or side effects related to the exposure; This spontaneous report was received from the Nurse, 47-year-old female, who refers to herself. Her medical history, concurrent conditions and concomitant therapies were not reported. On 07-MAR-2025, the nurse opened a sealed previously unopened carton of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) (strength 5MCG/0.5ML, lot #Y009551, expiration date: 08-DEC-2026) and 1 of 10 vaccine syringes tip/ luer lock was broken, "clean off and like it was decapitated" (Syringe issue). The tray was sealed with a cellophane cover and there was no damage to the shipping container that the reporter could recall and no damage to the carton, tray or cellophane either. There were no other syringes in the tray/ carton that were broken or damaged. The HCP stated there were no obvious shards of glass in the broken syringe or tray, but she could not be sure. A defect was noticed prior to breaking the seal of cellophane, but she did open the tray to inspect further. The HCP reported there was a hole at the top of the syringe where the tip/ luer lock broke off that was about the size of the hole that would be present if the tip was still intact, and the vaccine could leak out. The HCP stated there was no obvious fluid or dried residue in the tray, but upon picking up the syringe she stated the syringe felt wet and some of the vaccine might leaked out of a hole (at the top of the syringe where the break occurred) on her hand, but did not report any other adverse issues or side effects related to the exposure (Accidental exposure to product, Occupational exposure to product). None of the doses of Hepatitis B Vaccine (Recombinant) Suspension for injection (RECOMBIVAX HB) in the affected carton were administered. No additional adverse events.