Monoject 8881511110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20884521014937), received between Jun 8, 2017 and Dec 15, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Device Markings/Labelling Problem

  COVIDIEN MONOJECT 1ML INSULIN SAFETY SYRINGE FOUND TO HAVE MISPRINTED LABEL ON SYRINGE. PRINTING WAS TWISTED AROUND SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802102 ↗
• MalfunctionFeb 15, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT A NURSE WAS STUCK WITH A USED NEEDLE AFTER ATTEMPTING TO ENGAGE THE SAFETY MECHANISM. THE COLLEAGUE REPORTS THAT THE TUBE THAT IS PUSHED UP OVER THE NEEDLE AFTER USE AND THEN TWISTED TO LOCK BECAME STUCK HALFWAY UP AND DID NOT FULLY PROTECT THE NEEDLE. THE COLLEAGUE ATTEMPTED TO APPLY ADDITIONAL FORCE TO PUSH THE TUBE UP AND THEIR HAND SLIPPED CAUSING THEIR HAND TO STRIKE THE EXPOSED PORTION OF THE NEEDLE. ADDITIONAL INFORMATION RECEIVED ON 07FEB2024 STATED THAT THE NURSE WENT TO OCCUPATIONAL HEALTH AND RIGHT AFTER THE INCIDENT, THE NURSE WENT TO THE ED. FIRST AID WAS DONE AND BLOOD WAS DRAWN. ALL LABS WERE NEGATIVE. THE NURSE WILL HAVE MORE LABS DRAWN AT THE NEXT APPOINTMENT ON (B)(6) 2024.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18713922 ↗
• InjurySep 2, 2020Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTS THAT DURING AN INSULIN INJECTION, THEY GOT A DIRTY NEEDLE STICK BECAUSE THE SAFETY SHIELD ON THE DEVICE DID NOT LOCK INTO PLACE.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10485559 ↗
• InjuryJun 17, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THERE WAS A NEEDLE STICK INJURY WITH A MONOJECT INSULIN SYRINGE. THE NURSE ATTEMPTED TO PUSH THE SAFETY SHIELD UP OVER THE USED NEEDLE WITH THEIR LEFT INDEX FINGER AND THE SAFETY SHIELD DID NOT MOVE FREELY. IT WAS STUCK AND SEEMED LIKE IT WAS LOCKED IN THE ORIGINAL POSITION. A CLICK WAS NOT HEARD AND THE SHIELD DID NOT EXTEND FORWARD AS THE SAFETY SHIELD WAS NOT ABLE TO BE ACTIVATED. THE NURSE HAD TO GO TO OCCUPATIONAL HEALTH TO GET A TETANUS VACCINE. BLOOD WAS NOT DRAWN AND THERE WAS NO FURTHER MEDICAL INTERVENTION. THE NURSE FOLLOWED POLICY AND PROCEDURE FOR EMPLOYEE NEEDLE STICKS AT LUMC. SOURCE TESTING WAS SENT ON THE PATIENT AFTER THE NEEDLE STICK AND ALL RESULTS CAME BACK NEGATIVE. AT THIS TIME NO FOLLOW UP TESTING OR MEDICAL INTERVENTION IS REQUIRED AS ALL TESTING RESULTS WERE NEGATIVE PER OCCUPATIONAL HEALTH.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10165125 ↗
• MalfunctionDec 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT UPON DRAWING UP INSULIN, THE NEEDLE STAYED IN THE BOTTLE OF INSULIN WHEN THE SYRINGE WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492553 ↗
• MalfunctionJun 8, 2017Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER IS STATING THAT THE SAFETY SHEATH IS COMING OFF OF THE SYRINGE WHEN ACTIVATING OR IS NOT LOCKING/CONTINUOUSLY TWISTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6623114 ↗