Sex: M
Vaccine: MMR, MMR
Symptoms: Device connection issue, No adverse event, Syringe issue
Clinical narrative: No injuries or side effect reported / Was anyone injured as a result of the breakage? NO; "Plastic attachment where the needle twists on has broken off and remained in a patient's thigh after administration"; Plastic attachment where the needle twists on has broken off / Is the syringe broken into 2 or more pieces? YES / Does the syringe have a broken component? YES / Was there difficulty trying to attach the syringe needle to the syringe? YES; MMR II was re-administered; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; This spontaneous report has been received from a Registered Nurse via company presentative concerning to a 1-year-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies, and allergy/drug reactions were not reported.  On an unknown date in 2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (dose/frequency of administration, lot number and expiration were unknown as the product was reconstituted with the prefilled syringe was discarded).   On 09-FEB-2024, an email from the nurse reported that the plastic attachment of syringe of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) where the needle twists on, has broken off and remained in a patient's thigh after administration (Poor quality device used) (and it detached at the same location within the defective unit) of the sterile diluent (BAXTER STERILE DILUENT) (lot number reported as 1946077, date of expiration: 01-NOV-2025) (dose of administration not reported) for an unknown indication.  Additionally, it was reported that the hub was not broken, the needle and luer lock detached from the syringe barrel. This detachment occurred when the needle was still in the patient's thigh. The needle used was a "BD" needle, 1 inch, 25 gauge. The intended route of administration was to be administered intramuscularly (IM). The nurse was advised to forward an email with the picture of the product. No injuries or side effects were reported due to the event (no adverse event).  The following questions were asked to the reporter: Is the syringe broken into 2 or more pieces? Yes. If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Unknown. Provide the exact location of the breakage on the syringe? Unknown. Does the syringe have a broken component? Yes (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) If yes, describe in detail how it is broken. Unknown. Provide the exact location of the breakage on the syringe? Unknown. Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) Unknown Was anyone injured as a result of the breakage? No. If yes, provide brief description of injury N/A  Was there difficulty trying to attach the syringe needle to the syringe? Yes. If yes, describe Unknown If yes, was it supplied by MERCK: No If not supplied by MERCK, what type & brand, needle size & gauge was used?' Unknown Under what situation was this defect noticed: (select one) While the syringe was still in the tray? NO If yes, is there product (liquid or dried residue) in the tray? NA Is there any broken glass or other separated component in the tray? (if yes specify) NA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection? YES Was the syringe tip cap attached properly prior to use? UNKNOWN If no, describe issue: UNKNOWN Was the syringe tray intact and undamaged on receipt? UNKNOWN If no, describe damage. UNKNOWN If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed?  Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES (Accidental exposure to product). If complaint sample is not/cannot be returned, please provide reason: UNKNOWN.  Consequently, on an unknown date in 2024, the vaccine of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was readministered (Inappropriate schedule of product administration) along with an unknown dose of Hepatitis A Vaccine, Inactivated (manufacturer unknown) (strength, dose/route/frequency of administration was not reported) for prophylaxis.