Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y009348 | OT |
the PFS leaked from around the leurlock during administration; Initial caller was medical assistant who then placed MD on phone. HCP reported PQC for Sterile Diluent PFS. Caller states the PFS leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the saf; syringe leak; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection (PROQUAD), injection for prophylaxis, 0.5 milliliter, intramuscularly, lot number Y009348 which has been verified to be valid, expiration date reported and validated as 11-NOV-2025 (anatomical location, scheme and strength not provided) with sterile diluent solution for injection, lot number 1973529 which is an invalid lot number, expiration date 03-MAR-2026. On 20-FEB-2025, the prefilled syringe leaked from around the leurlock during administration. The reporter stated that the prefilled syringe leaked from around the leurlock during administration and then the needle and leurlock broke off when engaging the safety cap (poor quality deice used) (accidental underdose). Follow-up was received from reporter on 24-FEB-2025. The needle and leur lock broke off from the syringe. The louer lock itself was still inact and attached to the needle. The reporter confirmed needle detached from louer lock while engaging safety cap. It was not difficult to attach the needle but she could not get a good seal.
STERILE DILUENT