Received Jul 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMRV | MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) | MERCK & CO. INC. | UNK | Y018154 | — |
AE was filed since she stated that a patient missed a dose.; PFS leaked while injecting diluent into the PROQUAD vial; PFS leaked while injecting diluent into the PROQUAD vial; This spontaneous report was received from a medical assistant and a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-Jul-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, route of administration, lot #Y018154, expiration date: 29-Apr-2026) as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # 2050911, expiration date: 11-Feb-2027) pre-filled syringe (PFS). It was reported that PFS leaked while injecting diluent into the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vial (Syringe issue, Poor quality device used). She wasn't completely sure but she thought that leaking was at the Luerlock area. When she pulled out the reconstituted solution using a different syringe and needle, she only got 0.2ml so she put the solution back into the vial. She stated that a patient missed a dose (Product dose omission issue). No further information was available. It was also reported that the needle was not supplied by Company and it was used to instill the diluent. different syringe and needle were used between adding the diluent to the vial and withdrawing the reconstituted product from the vial. No damage or issues with the shipping container, carton that contained the syringe undamaged on receipt, plastic syringe tray. N injury as a result of the breakage. The syringe or it parts was not exposed to the patient's bodily fluids.
Diluent Mrk