Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y011484 | — |
No adverse event; syringe of MMRII leaked while administering vaccine to a patient; MMRII leaked while administering vaccine to a patient/partial vaccination; MMRII leaked while administering vaccine to a patient/partial vaccination; This spontaneous report was received from a nurse on 25-FEB-2025 and refers to a 1-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-FEB-2025, while administering the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y011484, expiration date: 27-JUN-2026) with the sterile diluent (DILUENT MRK) (lot #2031277, expiration date: 18-DEC-2026) to the patient, the syringe (25G, 5/8in) leaked (Syringe issue, Poor quality device used). The leakage occurred between the Luer Lock and syringe barrel. The syringe needle was attached or being attached to the syringe tip when the leaking occurred. There was no difficulty trying to attach the needle. There was nothing that was visible that could explain why the leaking occurred. Photos and product were not available for retrieval as product was disposed after partial vaccination (Accidental underdose). No additional information provided. No adverse event (AE) or product quality complaint (PQC) reported (No adverse event). At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was reported as not applicable.
Comments: not reported
DILUENT MRK