Monoject 8881511136Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884521014944), received between Aug 9, 2019 and Jul 6, 2022 — classified as 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Problem” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE EXTRA TWIST IN THE SYRINGE IS NOT WORKING. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14933266 ↗
• MalfunctionApr 30, 2021Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: THE SAFETY SHIELD REQUIRES TWO HANDS AND IN DOING SO THE NURSES ARE GETTING CLOSE TO BEING STUCK BECAUSE THEY ARE HAVING TO PUT A HAND BY THE NEEDLE INSTEAD OF A HINGE NEEDLE THAT THEY WERE USED TO. ALSO THE SAFETY COVERING WILL SLIDE OVER THE NEEDLE PRIOR TO ADMINISTRATION WHICH REQUIRES SOMEONE TO HOLD THAT DOWN TO BE ABLE TO ADMINISTER THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755531 ↗
• InjuryApr 28, 2021Fail-Safe Problem; Fail-Safe Problem

  THE NURSE RECEIVED A NEEDLE STICK FROM A CONTAMINATED NEEDLE.

  Patient problems: Insufficient Information; Needle Stick/Puncture

  MAUDE report 11739722 ↗
• InjuryApr 22, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SLIDE SAFETY FEATURE ON THE INSULIN SYRINGE DOES NOT STAY IN PLACE. IT CAN BE EASILY RETRACTED AND CAUSED A NEEDLE STICK DURING ACTIVATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11711055 ↗
• InjuryApr 22, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SLIDE SAFETY FEATURE ON THE INSULIN SYRINGE DOES NOT STAY IN PLACE. IT CAN BE EASILY RETRACTED AND CAUSED A NEEDLE STICK DURING ACTIVATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11710938 ↗
• MalfunctionApr 22, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SLIDE SAFETY FEATURE ON THIS INSULIN SYRINGE DOES NOT STAY IN PLACE. IT CAN BE EASILY RETRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709395 ↗
• InjuryApr 20, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER MEDICATION DELIVERY, WHEN THE SAFETY LATCH WAS EXTENDED FORWARD, THE NURSE PROCEEDED TO PLACE THE NEEDLE INTO THE SHARPS BOX VERTICALLY WITH THE NEEDLE FACING UP, THE WINGS DOWN BY THE PLUNGER CAUGHT THE EDGE OF THE SHARPS CONTAINER AS THE NURSE PUSHED THE SYRINGE INTO THE SHARP CONTAINER, THE SAFETY GLIDE, SLIDE DOWN ENOUGH TO CAUSE A NEEDLE PUNCTURE. THE CUSTOMER COULD NOT VERIFY IF AN AUDIBLE CLICK HEARD AFTER ACTIVATION. THE SHARPS CONTAINER WAS NOT FULL, ONLY HAD A FILL ITEMS IN IT AND IT WAS A LARGE CONTAINER. THE CUSTOMER FURTHER CONFIRMED, THE NEEDLE WAS CONTAMINATED. THE NURSE WASHED HER HANDS, LAB TESTS WERE PERFORMED AND HAD MEDICAL VISITS TO GO OVER THE RESULTS. THE LAB TEST RESULTS WERE NEGATIVE FOR BOTH SOURCE PATIENT AND THE NURSE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11698450 ↗
• MalfunctionApr 16, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SAFETY LOCK IS NOT GOOD, AND IT DOES NOT LOCK PROPERLY. THE ISSUE WAS DISCOVERED WHEN THE NEEDLES WERE TESTED AFTER OPENING THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680441 ↗
• MalfunctionApr 16, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SAFETY LOCK IS NOT GOOD, AND IT DOES NOT LOCK PROPERLY. THE ISSUE WAS DISCOVERED WHEN THE NEEDLES WERE TESTED AFTER OPENING THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680347 ↗
• MalfunctionApr 16, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE SAFETY LOCK IS NOT GOOD, AND IT DOES NOT LOCK PROPERLY. THE ISSUE WAS DISCOVERED WHEN THE NEEDLES WERE TESTED AFTER OPENING THE BOX. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679790 ↗
• MalfunctionApr 7, 2021Fail-Safe Problem; Fail-Safe Problem

  CUSTOMER REPORTS: BEFORE ADMINISTRATION OF THE INSULIN, WHEN THE NURSE WAS UNCAPPING THE NEEDLE THE SAFETY DEVICE SLIDES OVER THE NEEDLE AND IS LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627030 ↗
• InjuryApr 7, 2021Fail-Safe Problem; Fail-Safe Problem

  THE NURSE RECEIVED A NEEDLE STICK FROM A CONTAMINATED NEEDLE.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626928 ↗
• MalfunctionAug 26, 2020Reflux within Device; Reflux within Device

  CUSTOMER REPORTS: THE PLUNGER IS SEPARATING FROM THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10453590 ↗
• MalfunctionAug 9, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE ITEM'S SAFETY SHEATH WILL NOT LOCK IN PLACE. THERE WAS NO HARM TO THE STAFF OR PATIENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER AND IT WAS STATED THAT THE PRODUCT WAS BEING USED INCORRECTLY. THE NURSING STAFF WAS NOT TURNING THE CAP AFTER PUSHING UP THE SAFETY SHIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879257 ↗