Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | Y015995 | OT |
the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP also reports that some of the liquid came in contact with the patients skin.; HCP also reports that some of the liquid came in contact with the patients skin.; the needle hub became loose and began leaking between the plastic hub and the syringe itself; HCP reports she is unsure if patient received the entire dose; needle hub/luer lock Adaptor (syringe hub) became loose; This spontaneous report was received from a nurse and refers to a(n) patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 03-Jul-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #Y015995, expiration date: 24-Sep-2026 (information established upon internal review, also reported as 25-Sep-2026), 0.5 mL administered by intramuscular route (anatomical location was not provided)) for prophylaxis (reported as: immunization against MMR). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same date, while administering reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) using sterile diluent (MERCK STERILE DILUENT) syringe, the needle hub became loose and began leaking between the plastic hub and the syringe itself. It was confirmed that the luer lock Adaptor (syringe hub) became loose (Device connection loose, Syringe leak, Poor quality device used). HCP reported no issues with sterile diluent (MERCK STERILE DILUENT) syringe during preparation of dose. HCP reported that she was unsure if patient received the entire dose (Accidental underdose). HCP also reported that some of the liquid came in contact with the patient's skin (Accidental exposure to product, Exposure via skin contact). HCP was wearing gloves and therefore no contact was made with her skin. No symptoms report by patient at this time. HCP stated she has discarded the sterile diluent (MERCK STERILE DILUENT) syringe and was unable to provide photos. At the reporting time, the outcome of the events was unknown. The action taken with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live and sterile diluent was not applicable.
Diluent Mrk