Monoject 8881540133Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521082946), received between Oct 1, 2019 and Jul 2, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TIP IS NOT THREADING DOWN INTO THE SYRINGE ALL THE WAY CAUSING IT TO LEAK MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661116 ↗
• MalfunctionMar 29, 2024Crack; Crack

  THE CUSTOMER REPORTED THAT MULTIPLE VIAL ACCESS SYRINGES WERE CRACKING UPON USE. ONE SAMPLE WAS RETAINED. PER ADDITIONAL INFORMATION RECEIVED, THE TIP WAS CRACKING. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003002 ↗
• MalfunctionJan 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NURSE WAS NEEDING TO DRAW UP MEDICATION SO SHE OBTAINED A 3 ML SYRINGE WITH NEEDLELESS NEEDLE. NURSE REMOVED SYRINGE FROM PACKAGE, REMOVED NEEDLE CAP, AND INSERTED THE NEEDLE INTO THE VIAL. WHEN STARTING TO DRAW UP, THE FLUID LEAKED AROUND THE AREA WHERE THE NEEDLE ATTACHES WITH LUER LOCK TO THE SYRINGE. THE NEEDLE WAS NOT ON TIGHT WHICH CAUSED THE LEAKAGE. THIS ISSUE HAPPENS WITH MOST OF THESE SYRINGES THAT THE NEEDLE IS NOT FULLY ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610982 ↗
• MalfunctionJun 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: WHEN DRAWING UP MEDICATIONS THE SIDE OF VIAL ACCESS CANNULA STARTING SHOOTING OUT THE MEDICATION. IT SEEMS LIKE THERE IS A HOLE IN THE PLASTIC. IT IS NOT RELATED TO THE CANNULA BEING LOOSE ON THE SYRINGE BECAUSE IT WAS TIGHTENED WHEN SYRINGE APPEARED TO BE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14790465 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE RN WAS DRAWING UP MEDICATION FROM THE VIAL TO THE SYRINGE, THE VIAL ACCESS CANNULA HAD A SMALL HOLE IN THE SIDE AND MEDICATION WAS SQUIRTING OUT OF IT RESULTING IN WASTED MEDICATION. THE VIAL AND MEDICATION HAD TO BE WASTED AND A NEW VIAL WAS UTILIZED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720997 ↗
• MalfunctionJan 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED DURING USE, THEY NOTICED CONTAMINATION ON THE PLASTIC CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253415 ↗
• MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN PUTTING THE DEVICE INTO A VIAL AND TRYING TO DRAW UP THE MEDICATION, THE MEDICATION SQUIRTS OUT THE SIDE OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823356 ↗
• MalfunctionNov 8, 2019Crack; Crack

  THE CUSTOMER REPORTED THAT TWO SYRINGES WERE CRACKED WHEN OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9300355 ↗
• MalfunctionOct 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN DRAWING UP THE MEDICATION, THE MEDICATION SQUIRTS OUT FROM THE HOLES LOWER ON THE BLUNT TIP. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATED THAT WHEN THE SOLUTION IN THE SYRINGE IS BEING PUSHED OUT, THERE ARE TINY LITTLE STREAMS THAT COME OUT OF THE SYRINGE OTHER THAN FROM THE TIP OF THE CANNULA. THERE WERE TWO TINY DOTS NOTED THAT SPEW OUT THE LIQUID. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9169835 ↗
• MalfunctionOct 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE MONOJECT SYRINGE/NEEDLE COMBO HAD A BACK SPRAY WHILE A NURSE WAS WITHDRAWING MEDICATION. IT APPEARS THERE WAS A HOLE IN THE BLUNT TIP, ALLOWING IT TO SPRAY 90 DEGREES. SHE EXPERIENCED IT TWICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142178 ↗