Monoject 11832215 (UDI 10884521544550)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521544550), received between May 16, 2025 and May 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decoupling” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT NEEDLE/SYRINGE COMBO FELT SECURE, BUT WHEN ADMINISTERING INJECTION SOME OF THE LIQUID OVERFLOWED AROUND WHERE THE NEEDLE SCREWS ON, SOME DRIPPED ON FLOOR. IT WAS UNSURE HOW MUCH MEDICATION PATIENT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035682 ↗
• MalfunctionMay 16, 2025Decoupling; Difficult or Delayed Separation; Decoupling; Difficult or Delayed Separation

  "THE CUSTOMER REPORTED THAT THE RN DREW UP MEDICATION IN A MONOJECT 3 ML SYRINGE WITH HYPODERMIC SAFETY NEEDLE 22 G X 1-1/2"" SET. THE RN REMOVED THE CAP FROM THE NEEDLE, AND WAS PREPARING TO INJECT THE MEDICATION BUT BEFORE THEY INJECTED THE PATIENT THE NEEDLE FELL OFF OF THE SYRINGE ONTO THE FLOOR. THEY DIDN'T LOSE ANY MEDICATION AS THEY WERE ABLE TO GET A STERILE NEEDLE TO PUT ON THE SYRINGE AND ADMINISTER THE MEDICATION. THE RN SUPERVISOR STATES SHE VERIFIED WITH THE RN THAT THE RN DID TWIST THE NEEDLE ONTO THE HUB BEFOREHAND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035408 ↗