Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y011709 | — |
No adverse event; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; after she administered the injection and a "few drops" splattered in her face in which she had to flush her face and eyes.; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; The HCP reported that the hub/leur lock on the DILUENT syringe becomes loose causing the needle to fall off, usually prior to injection; This spontaneous report has been received from a nurse, regarding to herself a 25-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On an unknown date in 2024 (reported as few months ago), it was stated that the hub/leur lock on the sterile diluent solution for injection (BAXTER STERILE DILUENT) syringe became loose caused the needle to fell off, usually prior to injection and when they tried to screw the needle on tight, it caused the hub to became loose and detach and this was noticed immediately after removing from the tray, sometimes while attaching the needle, and once during an injection in which the needle was left in one patient (needle issue) (poor quality device used) (device connection issue). On 20-FEB-2025, after the nurse administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection (M-M-R II) injection, 0.5 mL, administered as prophylaxis (Lot No. Y011709 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 02-JUL-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not reported) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) injection, 0.5 mL, (Lot No. 2050911 has been verified to be a valid lot number for [sterile diluent solution for injection], expiration date was reported and upon internal validation established as 11-FEB-2027) (strength and route of administration were not provided) to an unspecified patient an unknown amount of few drops splattered in her face in which she had to flush her face and eyes (exposure via eye contact) (occupational exposure to product) On the same date (20-FEB-2025) the patient recovered from the events of exposure via eye contact and occupational exposure to product. No additional adverse event was provided (no adverse event).; Reporter's Comments: Keywords :
Diluent Merck Inj