Monoject 8881520251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521012141), received between Sep 23, 2016 and Sep 23, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 18, 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.

• MalfunctionSep 23, 2016Fluid/Blood Leak; Manufacturing, Packaging or Shipping Problem; Material Deformation

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTS SYRINGES LEAKED OUT AROUND THE PLUNGER DURING PRODUCT AND SOME THAT ARE DEFORMED VISIBLY, RIGHT OUT OF THE TRAY. THE DEFECTS THEY SEE ARE THE BLACK STOPPER BEING DEFORMED AND HAVING NO SEAL WITH THE BARREL OF THE SYRINGE. ALSO, THE TIP OF THE SYRINGE (WHERE THERE IS USUALLY A MALE TIP WITHIN THE LUER LOCK COLLAR) NOT HAVING THE MALE TIP.

  Patient problems: No Patient Involvement

  MAUDE report 5973270 ↗
• MalfunctionSep 23, 2016Fluid/Blood Leak; Component Missing; Material Deformation

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTS SYRINGES LEAKED OUT AROUND THE PLUNGER DURING PRODUCT AND SOME THAT ARE DEFORMED VISIBLY, RIGHT OUT OF THE TRAY. THE DEFECTS THEY SEE ARE THE BLACK STOPPER BEING DEFORMED AND HAVING NO SEAL WITH THE BARREL OF THE SYRINGE. ALSO, THE TIP OF THE SYRINGE (WHERE THERE IS USUALLY A MALE TIP WITHIN THE LUER LOCK COLLAR) NOT HAVING THE MALE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5973194 ↗