Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (RECOMBIVAX HB) | MERCK & CO. INC. | UNK | Y009436 | — |
no additional AE; was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe. Caller an; Event Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 12-MAR-2025, the patient was vaccinated with one dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) (valid lot number Y009436, expiration date: 12-FEB-2027) for prophylaxis (dose, dose number, anatomical location, route of administration was not provided). Medical assistant called stating another medical assistant at their facility was preparing one of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) prefilled syringe for administration (product preparation issue) when the luer lock detached while trying to attach the needle to the syringe (syringe issue, device issue). Caller stated the medical assistant attached a new needle to the syringe without the luer lock and administered the product to the patient without further issue (poor quality device used). Caller stated no patient symptoms have been reported. Caller stated the product was discarded after use so was not available for return however pictures were taken which they would send in. Caller declined needing a replacement for this product. No additional adverse event (AE) reported.