Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | 1 | Z006193 | — |
a nurse was administering a dose of RECOMBIVAX HB to an infant and the product leaked out; Poor quality device used; when they pushed down on the plunger to inject the product and when they went to remove the syringe, the needle disconnected from the syringe; This Spontaneous report was received from Pharmacist and referred to an infant patient of unknown exact age and gender. The patient's medical history, current conditions, past medications and concomitant medications were not reported. On 04-JAN-2026, patient was vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection at a dose of 1 dosage form (Lot Number: Z006193 with expiration date: 15-Nov-2027) on the leg (route of administration not provided) for prophylaxis; when the nurse was administering the vaccine, it leaked out between the needle and the luer lock when they pushed down on the plunger to inject the product and when they went to remove the syringe, the needle disconnected from the syringe and had to be manually removed from the patient's leg (Poor quality device used. Device connection issue, Product leakage). No additional PQC reported. The product was discarded and no photos are available.