Monoject 1182510Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521544680), received between Dec 17, 2019 and May 16, 2025 — classified as 4 injuries, 12 malfunctions.

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

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Break; Defective Component; Material Twisted/Bent; Break; Defective Component; Material Twisted/Bent

  THE CUSTOMER REPORTED ISSUES WITH SAFETY NEEDLES RESULTING IN NEEDLE STICKS AND NEAR MISSES HOWEVER SPECIFIC INCIDENT INFORMATION OR A QUANTITY OF INCIDENTS COULD NOT BE PROVIDED. THEY STATED THAT WHEN YOU CLOSE THE SAFETY CAP, IT ACTUALLY JUST BENDS THE NEEDLE. THE NEEDLES DO NOT FIT PROPERLY INTO THEIR SYRINGES, AND IT IS IMPOSSIBLE TO TIGHTEN THEM, AND THEY OFTEN COME UNSCREWED AND FALL OFF. THE PLASTIC SAFETY CAP ALSO BREAKS OFF EASILY OR GETS BENT WHEN MOVING IT OUT OF THE WAY TO GIVE AN INJECTION. MULTIPLE STAFF MEMBERS HAVE HAD EXPOSURES DUE TO NEEDLE POKES OR NEAR MISSES. THEY STATED THIS IS REALLY UNACCEPTABLE AND A MAJOR SAFETY CONCERN FOR THEIR STAFF WHO ARE FREQUENTLY WORKING WITH VIREMIC HIV PATIENTS. ADDITIONALLY THEY STATED THAT THE SAFETY DOESN'T ALWAYS ENGAGE WELL, THE NEEDLE IS MORE LIKELY TO DISLODGE FROM THE HUB THAN OTHER PRODUCTS, AND THE NEEDLES ARE MORE LIKELY TO BEND. ADDITIONAL INFORMATION RECEIVED ON 11OCT2024 STATED THAT THEY HAVE HAD OTHER STAFF MEMBER WHO DID NOT GET STUCK, BUT THE NEEDLE BENT AND ALMOST POKED THEM. ANECDOTALLY, OVER A YEAR AGO NOW THEY HAD THIS EXACT NEEDLE MALFUNCTION AND THEY WERE STUCK AFTER INJECTING A PATIENT AS THEY CLOSED THE S

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035765 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THEY ARE HAVING ISSUES WITH THE LUER LOCK HUBS NOT LOCKING WHICH HAS CAUSED THE CONTENTS (VACCINE) TO LEAK OUT INSTEAD OF BEING INJECTED INTO THE PATIENT. THEY HAVE ALSO HAD INSTANCES WHERE THE NEEDLE HAS COME OFF THE HUB AND THE VACCINE LEAKS OUT, WITH THE NEEDLE STAYING IN THE PATIENT'S ARM. NO INJURY OR MEDICAL TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035763 ↗
• MalfunctionMay 16, 2025Crack; Crack

  "THE CUSTOMER REPORTED A NURSE WAS GIVING VACCINE AND WHEN INJECTING THE PATIENT AND PUSHING THE PLUNGER, THE SYRINGE WAS CRACKED, AND THE MEDICATION SHOT OUT OF THE LUER LOCK AND NOT INTO THE PATIENT. THIS OCCURRENCE HAS HAPPENED MULTIPLE TIMES WITH THEIR CURRENT NEEDLES WITH DIFFERENT NURSES. THE NEEDLES CRACK THE SYRINGE WHEN SCREWED ONTO THE SYRINGE THAT THE NEEDLE TEARS INTO THE SKIN. THE SENSATION IS THAT THE NEEDLE HAS NO CUT"".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035623 ↗
• MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT AN IM INJECTION WAS ORDERED FOR A PATIENT. WHEN ADMINISTERING THE INJECTION TO THE PATIENT, THE NEEDLE SPRAYED THE MEDICATION OUT TOWARDS THE WALL AND DID NOT PERFORM CORRECTLY. IT IS UNKNOWN HOW MUCH MEDICATION WAS ACTUALLY ADMINISTERED TO PATIENT BECAUSE OF THIS. NO FURTHER DETAILS WILL BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035608 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "THE CUSTOMER REPORTED THAT A CMA IMPLEMENTED THE SAFETY CAP ON THE SYRINGE BY PUSHING THE SAFETY CAP AGAINST THE TABLE. THE CMA THEN WENT TO SET THE SYRINGE ON THE TABLE WITH THEIR RIGHT HAND AND WITH THEIR LEFT HAND GRABBED A BAND-AID FOR THE PATIENT. THE CMA WAS STUCK ON THE LEFT-HAND FOREFINGER WITH THE NEEDLE. IT WAS STATED THAT AFTER THE STICK, THE NEEDLE HAD UNSCREWED AND THE VACCINE'S PRE-FILLED SYRINGE FELL TO THE FLOOR AND THAT IS WHEN THE CMA NOTICED THAT THE NEEDLE HAD APPARENTLY BENT SEPARATING FROM THE SAFETY CAP AND HAD MALFUNCTIONED ALLOWING THE NEEDLE TO NOT BE PROTECTED BY THE SAFETY CAP. ANECDOTALLY, THE CUSTOMER REPORTED THAT THIS EVENT OCCURRED ON NUMEROUS INSTANCES. SPECIFIC INCIDENT INFORMATION WAS NOT PROVIDED HOWEVER THEY STATED THAT WHEN YOU CLOSE THE SAFETY CAP, IT ACTUALLY JUST BENDS THE NEEDLE. THE NEEDLES DO NOT FIT PROPERLY INTO THEIR SYRINGES, AND IT IS IMPOSSIBLE TO TIGHTEN THEM, AND THEY OFTEN COME UNSCREWED AND FALL OFF. THE PLASTIC SAFETY CAP ALSO BREAKS OFF EASILY OR GETS BENT WHEN MOVING IT OUT OF THE WAY TO GIVE AN INJECTION. MULTIPLE STAFF MEMBERS HAVE HAD EXPOSURES DUE TO NEEDLE POKES OR NEAR MISSES. THEY STATED THIS IS REALLY UNACCEPTABLE A

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035465 ↗
• MalfunctionOct 23, 2024Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT A CMA ADMINISTERED A VACCINE TO A PATIENT AND IMPLEMENTED THE SAFETY CAP ON THE SYRINGE BY PUSHING THE SAFETY CAP AGAINST THE TABLE. THE CMA THEN WENT TO SET THE SYRINGE ON THE TABLE WITH THEIR RIGHT HAND AND WITH THEIR LEFT HAND GRABBED A BAND-AID FOR THE PATIENT. THE CMA WAS STUCK ON THE LEFT-HAND FOREFINGER WITH THE NEEDLE. IT WAS STATED THAT AFTER THE STICK, THE NEEDLE HAD UNSCREWED, AND THE VACCINE'S PRE-FILLED SYRINGE FELL TO THE FLOOR AND THAT IS WHEN THE CMA NOTICED THAT THE NEEDLE HAD APPARENTLY BENT SEPARATING FROM THE SAFETY CAP AND HAD MALFUNCTIONED ALLOWING THE NEEDLE TO NOT BE PROTECTED BY THE SAFETY CAP. ADDITIONAL INFORMATION RECEIVED ON 11OCT2024 STATED THAT THE CMA WAS SEEN IN EMPLOYEE OCCUPATIONAL HEALTH & WELLNESS, HAD BLOOD DRAWN, AND IS ON MEDICATIONS FOR PROPHYLAXIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20517237 ↗
• MalfunctionNov 30, 2023Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED A FAULTY SAFETY DEVICE AND STATED THAT WHEN YOU WENT TO CLOSE THE SAFETY CLIP IT EITHER BENT THE NEEDLE OR THE CLIP DID NOT CLICK INTO PLACE LEAVING THE NEEDLE EXPOSED RESULTING IN A NEEDLE STICK. BLOOD WORK WAS DONE ON THE PATIENT AND EMPLOYEE INVOLVED PER THEIR PROTOCOL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18241671 ↗
• MalfunctionOct 26, 2023Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED FAULTY SAFETY DEVICE (MULTIPLE NEEDLE STICKS). ADDITIONAL INFORMATION RECEIVED ON 06NOV2023 STATED THAT THEY CANNOT SAY AN EXACT NUMBER BUT THE PRODUCT WAS CHEAPLY MADE SO WHEN YOU WENT TO CLOSE THE SAFETY CLIP IT EITHER BENT THE NEEDLE OR THE CLIP DID NOT CLICK INTO PLACE LEAVING THE NEEDLE EXPOSED. THEY HAD TWO NEEDLE STICKS. BLOOD WORK WAS DONE ON THE PATIENT AND EMPLOYEE INVOLVED PER THEIR PROTOCOL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18016562 ↗
• MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE CLINICIAN WENT TO GIVE THE VACCINE, THEY NOTICED THAT SOME OF THE VACCINE CAME OUT OF THE BASE OF THE NEW NEEDLES THAT THEY GOT PRIOR TO ADMINISTRATION. THEY REPORTED THE NEEDLES FELT FLIMSY DURING ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17758560 ↗
• MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT ONE NEEDLE LEAKED VACCINE PRIOR TO ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757935 ↗
• MalfunctionAug 4, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A PEDIATRIC PATIENT (6 MONTHS OF AGE) WAS TO RECEIVE A PRE-FILLED INJECTION OF PEDIARIX I.M. WHEN THE NURSE PUSHED ON THE SYRINGE PLUNGER, LIQUID SHOT OUT OF THE SIDES ONTO THE NURSE'S GLOVED HAND AND ON THE PAPER COVERING ON THE EXAM TABLE (AS BOTH WERE SUDDENLY WET). THE NURSE IS CERTAIN THAT ALTHOUGH THE CHILD WAS STUCK WITH THE NEEDLE, NONE OF THE MEDICATION WAS RECEIVED. ON CLOSER EXAMINATION OF THE SYRINGE, IT WAS NOTICED THAT THERE WAS A CRACK IN THE LUER LOCK PIECE OF THE NEEDLE HUB WHICH CAUSED THE VACCINE TO SHOOT OUT THE SIDES. AFTER EXAMINATION, THE STAFF DISPOSED OF THE NEEDLE AND THE SYRINGE, SO THERE IS NOTHING TO RETURN TO THE MANUFACTURER. STAFF INSPECTED SEVERAL OTHER NEEDLES FROM THAT LOT AND DID NOT IDENTIFY ANY OTHER DEFECTS. THE INFANT HAD TO RETURN TO BE REINJECTED THE NEXT DAY WHICH WAS UPSETTING TO ALL INVOLVED BUT THERE WAS NO ACTUAL HARM DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166315 ↗
• MalfunctionDec 1, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE NURSE WAS HOLDING THE SYRINGE IN HER RIGHT HAND AND WHILE INSERTING IT INTO THE SHARPS BOX, HOLDING THE FLAP WITH HER LEFT HAND, POKED HER LEFT INDEX FINGER. SHE BELIEVED THAT SHE HAD ENGAGED THE SAFETY WITH THE RIGHT THUMB BEFORE DISCARDING, BUT IT APPARENTLY IT HAD NOT ENGAGED. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND THERE WAS NO PATIENT INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12912800 ↗
• InjuryDec 19, 2019Detachment of Device or Device Component; Fail-Safe Problem; Detachment of Device or Device Component; Fail-Safe Problem

  THE CUSTOMER REPORTED AFTER GIVING HEPARIN TO A PATIENT, WHILE ATTEMPTING TO ENGAGE THE SAFETY, THE NEEDLE FELL OFF AND POKED THE USER'S FORTH FINGER. THE CUSTOMER FURTHER STATED THE PUNCTURE WAS TREATED IN EMPLOYEE HEALTH AND ALL LAB RESULTS WERE NORMAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9495082 ↗
• InjuryDec 18, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER GIVING HEPARIN TO A PATIENT, WHILE ATTEMPTING TO ENGAGE THE SAFETY, THE SAFETY SPUN OUT OF THE WAY AND CUT HER LEFT INDEX FINGER WHILE ENGAGING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE CUT WAS TREATED IN EMPLOYEE HEALTH. ALL LAB RESULTS WERE NORMAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9489963 ↗
• InjuryDec 17, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED THAT AFTER A HEPARIN INJECTION, THE NEEDLE FELL OF THE SYRINGE DURING ACTIVATION OF THE SAFETY SHIELD AND PUNCTURED THE NURSES LEFT THUMB. THE PUNCTURE WAS TREATED IN EMPLOYEE HEALTH. ALL LAB RESULTS WERE NORMAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9483638 ↗
• InjuryDec 17, 2019Fail-Safe Problem; Fail-Safe Problem

  THE CUSTOMER REPORTED AN INCIDENT WHEREIN THE EMPLOYEE INDICATED THAT THE NEEDLE WAS TIGHTENED PRIOR TO USE BUT FELL OFF THE SYRINGE DURING THE SAFETY SHIELD ACTIVATION. THE PUNCTURE WAS TREATED IN EMPLOYEE HEALTH. THE LAB RESULTS WERE NORMAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9483616 ↗