Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | UNK | — | — |
Caller stated a patient was stuck twice while vaccinating with VARVAX; No adverse side effects were reported; leaky diluent syringes; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT ATTACHING TO THE LUER LOCK CORRECTLY.; LUER LOCK SEEMS LIKE IT WON'T GET A TIGHT FIT, WHEN YOU GET TOO TIGHT IT KIND OF PULLS SIDEWAYS o Is there difficulty attaching the Syringe Needle to the Syringe? YES- BUT NOT SECURLEY; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT ATTACHING TO THE LUER LOCK CORRECTLY.; This spontaneous report was received from a nurse via field base employee (FBE) and refers to a 1-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. The reporter stated that she had a complaint regarding sterile diluent (BAXTER STERILE DILUENT) solution for injection, as "leaky diluent syringes" were reported by several nurses at the health department", she also stated that luer lock seemed like it wouldn't get a tight fit, when they got it too tight it kind of pulled sideways, they could attach the needle to the syringe but not securely, so leaking occurred while attaching the needle to the syringe. The reporter informed that this occurred with 3 syringes from the same lot#1973253 (expiration date: 22-Feb-2026), but came from different boxes. Then on an unspecified date a patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection as prophylaxis (dose, route of administration, lot # and expiration date were not reported) reconstituted with one of these sterile diluent (BAXTER STERILE DILUENT) syringes, and stated that the patient was stuck twice while being vaccinated, but no adverse side effects were reported. The reporter stated that the syringe leaked during this administration since the needle was not attaching to the luer lock correctly. Caller did say it happened more than once with this lot (not clarified). Only one of the involved syringes could be returned. Lot # is being requested and will be submitted if received.
Sterile Diluent