Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | OT |
No additional AE; The Luer Lock was loose and spins; needle and syringe tip were left in the patients arm; MMR-2 reconstituted&drawn up in a Merck sterile diluent syringe separated towards the end of the administration/A component of Syringe is Damaged/Defective or has Separated from the body of syringe;location of issue Syringe tip and Luer-lock Collar; This spontaneous report was received from a medical assistant and refers to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 17-Oct-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection, administered by intramuscular route in the arm (exact dose, dose number, lot # and expiration date were not reported), for immunization. The vaccine was reconstituted with sterile diluent solution for injection (lot #2053196, expiration date: 07-Nov-2027) (lot #2053196, expiration date: 07-Nov-2027). The luer lock of syringe was loose and spined and at the end of administration, syringe tip and luer lock collar separated from the body of syringe (also reported as "a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that was reconstituted and drawn up in a Merck sterile diluent syringe separated towards the end of the administration") (Poor quality device used, Device connection issue). The needle and syringe tip were left in the patient's arm (Complication of device removal). The patient received a full dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and no one was injured. Replacement was not requested. No additional adverse event was reported. Lot# is being requested and will be submitted if received.
STERILE DILUENT/VACCINES SYRINGE 00006417589