Received Jun 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | X028353 | OT |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | 1973244 | — |
No adverse event; HCP reported PQC for 3 Sterile Diluent PFS that all occurred during one vaccination visit: Event #1: HCP reports after she diluted MMR II with sterile Diluent PFS. Upon withdrawing the MMR II vaccine back into the PFS- the Barrel of the Sterile D; Syringe issue; Complication of device removal; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-MAY-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) 0.5 ml (lot #X028353, who had been verified to be a valid lot number, expiration date: 11-DEC-2025) administered by Intramuscular route as prophylaxis; sterile diluent (lot #1973244, who had been verified to be a valid lot number, expiration date: 01-MAR-2026). It was reported that the health care professional was administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) and the needle and leurlock separated from the barrel of the prefilled syringe (PFS). The needle and leurlock remained in the patient and the PFS separated from the leurlock (Poor quality device used, Syringe issue, Complication of device removal). In addition some information about syringe was reported as: health care professional reported after she diluted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) with sterile Diluent PFS. Upon withdrawing the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) vaccine back into the PFS- the Barrel of the Sterile Diluent separated from the Needle and Leurlock- The Needle and Leurlock remained in the stopper of the vial and the barrel of the PFS was separate. The caller states all components were intact (Not broken) but were just separated. Also, after Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) (not related to #1 or #2 report) was administered. HCP went to engage the safety cap on the needle and the needle and leurlock "Flew across the room". HCP states no injuries from this incident. HCP confirmed there were no broken components- The leurlock and needle separated from the barrel of the PFS. No additional adverse events.