Monoject 8881225190Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521013018), received between Jun 4, 2019 and Sep 21, 2021 — classified as 3 injuries, 11 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE NEEDLES ARE LEAKING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505757 ↗
• MalfunctionApr 29, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE DEVICE NEVER GAVE A FLASH OR WOULD LET THEM PULL BACK. THEY HATE HAVING TO STICK A SECOND TIME. IT FELT UNSAFE AND WAS VERY HARD TO SHEATH THE SAFETY. THEY TRIED AGAIN WITH THE SAME ISSUES, AFTER THAT THEY REFUSED TO USE THEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11746153 ↗
• MalfunctionApr 28, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT DUE TO THE NATURE OF THE GRIP WINGS BEING SO MOBILE AROUND THE NEEDLE, MULTIPLE TIMES AS THEY PUSHED THE NEEDLE FORWARD TO POKE INTO A PATIENT¿S SKIN, THE NEEDLE GOT STUCK MIDWAY OR DID NOT MOVE FORWARD AFTER HITTING THE SKIN AS THE WINGS MOVED FORWARD UP THE NEEDLE INSTEAD WHICH COMPROMISES PATIENT CARE AS IT PREVENTS THE NEEDLE FROM GOING INTO THE VEIN RESULTING IN THE NEED TO POKE ANOTHER TIME IN ANOTHER SPOT. IT ALSO CAUSED THE VEIN TO BLOW DUE TO UNINTENDED NEEDLE MOVEMENTS.

  Patient problems: Rupture

  MAUDE report 11742015 ↗
• MalfunctionApr 28, 2021Detachment of Device or Device Component; Fail-Safe Did Not Operate; Detachment of Device or Device Component; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT WHEN THEY TRIED TO CLOSE THE NEEDLE AFTER WITHDRAWING IT FROM THE PATIENT¿S ARM, THE NEEDLE POPPED OFF FROM THE TUBING WHILE THEY WERE TRYING TO ENGAGE THE SAFETY LOCK. THEY WERE UNABLE TO SAFELY CLOSE THE NEEDLE. BLOOD WAS DRIPPING FROM THE TUBING AND FROM THE DISENGAGED NEEDLE. THEY HAD TO CARRY IT TO THE SHARPS BIN UNCOVERED. THE ISSUE DID NOT COMPROMISE PATIENT CARE AS THE DRAW WAS ALREADY COMPLETED. ADDITIONAL INFORMATION PROVIDED ON 29-APR-2021 STATED THAT IT WAS THE COLORED PLASTIC WING PIECE THAT DETACHED FROM THE TUBING, NOT THE NEEDLE. THE CUSTOMER ALSO STATED THAT ONCE THE SAFETY LOCK WAS ENGAGED, THE NEEDLE WAS NOT SECURE; THE WINGS WERE STILL ABLE TO MOVE BACK AND FORTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741366 ↗
• MalfunctionApr 13, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY IS NOT ENGAGING EASILY OVER THE NEEDLE AFTER THE DRAW IS FINISHED; AS THEY PULLED UP ON THE NEEDLE SAFETY TO COVER THE NEEDLE AFTER THE DRAW, THE SAFETY DID NOT ENGAGE AND THEY STRUGGLED TO GET IT TO WORK AFTER MULTIPLE TIMES OF PULLING/PUSHING IT UP. A NEEDLE STICK DID NOT OCCUR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661350 ↗
• MalfunctionApr 13, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY IS NOT ENGAGING EASILY OVER THE NEEDLE AFTER THE DRAW IS FINISHED; AS THEY PULLED UP ON THE NEEDLE SAFETY TO COVER THE NEEDLE AFTER THE DRAW, THE SAFETY DID NOT ENGAGE AND THEY STRUGGLED TO GET IT TO WORK AFTER MULTIPLE TIMES OF PULLING/PUSHING IT UP. A NEEDLE STICK DID NOT OCCUR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661312 ↗
• MalfunctionApr 13, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY CAP FELL OFF BEFORE BEING READY FOR USE. ALSO, WHEN POKING THE PATIENT, THE SAFETY DEVICE WOULD SLIDE UP WHEN MOVING THE NEEDLE IF IT WAS NOT HELD PROPERLY AND IT DID NOT ALWAYS LATCH WHEN TRYING TO SLIDE THE SAFETY UP AFTER THE DRAW. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661147 ↗
• MalfunctionApr 13, 2021Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT THE SAFETY WAS NOT SECURED ENOUGH TO PREVENT IT FROM ENGAGING WHILE REDIRECTING IN THE PATIENT¿S VEIN. (I.E. THEY WERE MOVING THE NEEDLE TO THE LEFT, THE WINGS ARE ON THE SAFETY SO AS THEY HOLD THE WINGS TO MANIPULATE IT, THEY LOSE HALF OF MY NEEDLE LENGTH). IT HAS HAPPENED SO OFTEN THAT THEY HAD TO START HOLDING IT DIFFERENTLY IN ORDER TO KEEP IT FROM HAPPENING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661132 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem

  THE CUSTOMER REPORTED AN ISSUE WITH THE BLUE WINGS BREAKING OFF EASILY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 18-AUG-2020 STATED THAT THE EMPLOYEE WAS STUCK WITH THE NEEDLE. THE NEEDLE WAS CLEAN AS IT HAPPENED BEFORE HE DREW THE PATIENT. HE WASHED WITH SOAP AND WATER THEN APPLIED A BANDAID. NO BLOODWORK WAS DONE ON THE EMPLOYEE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10423095 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AN ISSUE OF THE BLUE WINGS BREAKING OFF EASILY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423094 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED AN ISSUE OF THE BLUE WINGS BREAKING OFF EASILY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10423066 ↗
• InjuryAug 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PATIENT WAS HAVING LABS DRAWN. AFTER THE TOURNIQUET WAS TAKEN OFF THE PATIENT¿S ARM AND A COTTON BALL PLACED OVER THE NEEDLE TO REMOVE, THE NEEDLE DISLODGED FROM BASE AND WAS LEFT IN THEIR ARM. THE NEEDLE HAD TO BE PULLED OUT WITHOUT THE SAFETY BEING ATTACHED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE NEEDLE DETACHED CLEANLY FROM THE HUB. THE NEEDLE WAS IN THE PATIENT'S ARM FOR ONE MINUTE. THE NEEDLE WAS REMOVED BY THE CLINICIAN USING THEIR HAND/FINGERS WITH GLOVES ON. THERE WERE NO INJURIES TO THE PATIENT AND NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10422587 ↗
• InjuryJun 13, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SAFETY LOCK MECHANISM ON THE 23 GAUGE BUTTERFLY NEEDLE DOES NOT LOCK SECURELY AND IS MADE OF A VERY THIN PIECE OF FOIL. THE SAFETY COVER WAS ACTIVATED BY THE HEALTH CARE PROVIDER (HCP) AND THE HCP PUT GAUZE AND TAPE ON THE PATIENT AND BEGAN TO PICK UP THE NEEDLE AND TRASH. WHILE DOING SO, THE SAFETY SHIELD SLID DOWN AND THE NEEDLE STUCK THE HCP IN THE RIGHT THUMB.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8695846 ↗
• InjuryJun 4, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THE SAFETY LOCK MECHANISM ON THE 23 GAUGE BUTTERFLY NEEDLES DO NOT LOCK SECURELY AND ARE MADE OF A VERY THIN PIECE OF FOIL. THE HEALTH CARE PROVIDER (HCP) DREW A PATIENT WITH A 23G SYRINGE NEEDLE. AS THEY WERE TAKING IT OUT, THERE WAS A DROP OF BLOOD AT THE END OF THE NEEDLE. THE HCP TOOK THE NEEDLE AND MOVED IT TO THE GAUZE TO TAKE OFF THE BLOOD DROP AND WENT TOO CLOSE TO THEIR FINGER AND STUCK THEIR LEFT INDEX FINGER. THE HCP DISPOSED OF ALL SUPPLIES, TOOK OFF THEIR GLOVES AND WASHED THEIR HANDS. THEY WERE BLEEDING SO WENT TO THE LAB IMMEDIATELY AND CALLED THEIR SUPERVISOR.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8666918 ↗