Received Mar 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z005719 | — |
No additional AE reported; as she attempted to administer the product, she "pushed down on the plunger and it came out where the syringe tip attaches to the hub of the needle; when she tried to administer the reconstituted MMR II, it "all leaked out of the syringe"; she "pushed down on the plunger and it came out where the syringe tip attaches to the hub of the needle".; product leaked onto patient; This spontaneous report was received from a health business provider (HBP) who was reporting on behalf of physician and refers to a 12-month-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-Feb-2026, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), single dose, lot #Z005719, expiration date: 07-Mar-2027 (dose, anatomical location and route of administration were not provided). The vaccine was reconstituted with sterile diluent, single dose, lot #Z010872, expiration date: 25-Apr-2028 (dose, anatomical location, route of administration were not reported). The vaccine was administered for prophylaxis. When the physician went to administer the reconstituted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), it all leaked out of the syringe. The syringe was described as faulty sterile diluent syringe. Physician stated as she attempted to administer the product, she pushed down on the plunger and it came out where the syringe tip attaches to the hub of the needle. When the physician pushed the plunger of the syringe, the reconstituted product spilled out between the hub of the needle and syringe tip. She stated the needle hub was securely attached to the syringe. The product leaked onto patient and patient had to receive a second needle stick to get a complete dose of the vaccine (the dose was incomplete, however the patient received additional vaccination to receive full dose). It was confirmed that no issues or defects were noted, just the leaking. The physician was an experienced user. The issue occurred during vaccine administration. It was reported that Company did not supply the syringe needle or vial adaptor and/or plastic dosing syringe. The vaccine component and sterile diluent were stored properly (vaccine in the freezer and diluent in the refrigerator). No adverse reactions were reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02949810-02949806 , CLIC number : , ESTAR number : , IRMS number : 500TP00000ehBarYAE|18022026230033|1205 , Central date : 2026-02-19 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02949810 , MNSC interaction number : 02949806 , Integration log UniqueID : 500TP00000ehBarYAE|18022026230033|1205 , Service cloud CaseID : 500TP00000ehBarYAE
sterile diluent