Monoject 1186000777Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10884521010864), received between May 14, 2019 and Dec 19, 2025 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break

  FROM STAFF: 60ML MONOJECT SYRINGE PLUNGER WAS BROKEN AND SHARP. I WAS DRAWING UP FLUIDS FROM AN IV BAG AND NOTED THE PLUNGER WAS OBVIOUSLY DEFECTIVE, PACKAGING WAS INTACT AND LOOKED NEW. THIS SEEMS TO BE A DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849755 ↗
• MalfunctionApr 4, 2022Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGE TIP BREAKS OFF OF THE SYRINGE WHEN DRAWING UP MEDICATION RESULTING IN SPILLS. THIS IS HAPPENING WHILE MAKING HAZARDOUS COMPOUNDS (CHEMO) AS WELL AS NON-HAZARDOUS. THERE ALSO IS NO EXPIRATION DATE ON THE STERILE SYRINGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13999062 ↗
• MalfunctionMar 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE CLINICIAN IN FACILITY FOUND THE SYRINGE WAS DAMAGED. THE LUER LOCK TIP OF THE SYRINGE WAS SHEERED OFF AND A NEEDLE COULD NOT BE ATTACHED. THE TIP WAS NOT IN THE PACKAGING. THERE WAS ALSO A CHALKY WHITE SUBSTANCE FOUND AROUND THE TIP AREA. THE CHALKY SUBSTANCE WAS ON THE TIP OF THE SYRINGE AND ALSO INSIDE THE TUBE. THEY ONLY FOUND ONE SYRINGE IN THEIR INVENTORY WITH THIS ISSUE. IT WAS FOUND LIKE THIS IN THE PACKAGING WHEN THE CLINICIAN OPENED THE PACKAGING TO USE THE SYRINGE. THE SYRINGE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789766 ↗
• MalfunctionFeb 17, 2022Break; Fluid/Blood Leak

  COVIDIEN MONOJECT 60ML LL SYRINGES-THE SYRINGE TIP BREAKS OFF OF THE SYRINGE WHEN DRAWING UP MEDICATION RESULTING IN SPILLS. THIS IS HAPPENING WHILE MAKING HAZARDOUS COMPOUNDS (CHEMO) AS WELL AS NON-HAZARDOUS. THERE ALSO IS NO EXPIRATION DATE ON THE STERILE SYRINGE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13561073 ↗
• MalfunctionDec 17, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE 60 CC SYRINGES HAVE BEEN BREAKING WHEN CONNECTING A PHASEAL INJECTOR. IT WAS REPORTED THAT THE SYRINGE LUER LOCK PLASTIC BROKE WHEN STAFF WAS PUTTING AIR INTO A VIAL. THE PHASEAL INJECTOR WOULD NO LONGER STAYS ON THE SYRINGE AND CAN EASILY BEND AND COME OFF. THERE WAS BROKEN PLASTIC IN BOTH THE TIP OF THE SYRINGE AND IN THE PHASEAL INJECTOR. THEY STATED THAT THEY DID NOT HAVE MEDICATION IN THE SYRINGE DURING THE TIMES THAT THEY HAVE FAILED, BUT IF IT WERE TO OCCUR THIS COULD EASILY SPILL OUT ONTO STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026819 ↗
• MalfunctionNov 8, 2021Contamination; Contamination

  THE CUSTOMER REPORTED A PIECE OF PLASTIC ADHERED TO THE BLACK PLUNGER FACE ON THE FLUID PATH SIDE OF THE PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771655 ↗
• MalfunctionMay 19, 2021Contamination; Contamination

  THE CUSTOMER REPORTED THE SYRINGE APPEARS TO HAVE FLAKES OF SOME SORT IN THE BARREL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849031 ↗
• MalfunctionApr 26, 2021Break; Break

  THE CUSTOMER REPORTED THE 60 ML COVIDIEN SYRINGE BROKE AT THE TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726943 ↗
• MalfunctionMar 4, 2021Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation

  THE CUSTOMER REPORTED THAT SHORTLY AFTER CHANGE OF SHIFT, IT WAS NOTED THAT THE LIPIDS LINE WAS WET. TRACING BACK UP TO THE SPOT WHERE THE SYRINGE WAS SCREWED INTO THE LINE'S HUB THERE WAS A LARGE AMOUNT OF LEAKAGE. THE END OF THE SYRINGE WAS BROKEN. LIPIDS WERE STOPPED AND DISCONNECTED FROM THE PATIENT AND THE NURSE PRACTITIONER WAS MADE AWARE. THE PHARMACY WAS CONTACTED AND THEY STATED THAT IT WAS ALL PREPARED UNDER A HOOD TO MAINTAIN STERILITY SO THE WHOLE SET UP (TPN, TOTAL PARENTERAL NUTRITION, INCLUDED) WOULD NEED TO BE REDONE. THE NURSE PRACTITIONER WAS MADE AWARE AND STATED THAT THE PATIENT COULD GO WITHOUT LIPIDS FOR THE NIGHT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATED THAT THERE WAS NO IMPACT TO THE PATIENT AND NO INTERVENTION NEEDED FOR THE PATIENT OTHER THAN REPLACING THE MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412773 ↗
• MalfunctionFeb 1, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THEY WERE PUSHING HAZARDOUS MEDICATION INTO IVPB AND THE DRUG DRIPPED OUT. THERE WAS POSSIBLY A CRACK IN THE SYRINGE HUB OR DRUG SPIRO. THERE WAS NO HARM TO THE PATIENT, THE ISSUE OCCURRED IN PREPARATION IN THE HOOD AND THEY MADE A NEW INFUSION FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263375 ↗
• MalfunctionOct 22, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THERE IS A PIECE OF PLASTIC INSIDE THE SYRINGE BARREL.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10721898 ↗
• MalfunctionSep 14, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE LUER LOCK CONNECTION BROKE OFF THE SYRINGE DURING ADMINISTRATION. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10532197 ↗
• MalfunctionAug 20, 2020Break; Break

  CUSTOMER REPORTS: THE 60 ML SYRINGES ARE BREAKING AT THE TIP DURING THE PREPARATION PROCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10430546 ↗
• MalfunctionJul 28, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT ONE OF THE NURSES FOUND A PLASTIC PART INSIDE THE SYRINGE BARREL, AFTER JUST OPENING IT TO FILL.

  Patient problems: No Patient Involvement

  MAUDE report 10331674 ↗
• MalfunctionJul 22, 2020Material Discolored; Material Discolored

  THE CUSTOMER REPORTS UPON INSPECTING A 60 ML MONOJECT SYRINGE PRIOR TO USE, A PEDIATRIC PHARMACY TECHNICIAN IDENTIFIED SOME ORANGE/BROWN DISCOLORATION ON THE BARREL OF THE SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 10311978 ↗
• MalfunctionJul 2, 2020Material Discolored; Material Discolored

  THE CUSTOMER STATES THE SYRINGES ARE DISCOLORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223976 ↗
• MalfunctionApr 8, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTS THAT DURING PREPARATION, THE SYRINGE TIP WAS INTACT WHEN REMOVED FROM THE WRAPPER, THE COMPOUNDING TECHNICIAN SUCCESSFULLY ATTACHED THE PHASEAL LUER LOCK INJECTOR ONTO THE SYRINGE, BUT WHEN THE TECHNICIAN ATTACHED THE PHASEAL LUER LOCK INJECTOR TO THE PHASEAL ¿Y¿ INFUSION ADAPTER, THE SYRINGE TIP BROKE OFF. THIS RESULTED IN CHEMO SPILLS INSIDE THE VERTICAL FLOW HOOD.

  Patient problems: No Patient Involvement

  MAUDE report 9936368 ↗
• MalfunctionApr 8, 2020Break; Break

  THE CUSTOMER REPORTS THAT DURING PREPARATION, THE SYRINGE TIP WAS INTACT WHEN REMOVED FROM THE WRAPPER, BUT WHEN THE COMPOUNDING TECHNICIAN ATTEMPTED TO TWIST THE PHASEAL LUER LOCK INJECTOR ONTO THE SYRINGE, THE TIP BROKE OFF.

  Patient problems: No Patient Involvement

  MAUDE report 9936338 ↗
• InjuryApr 3, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT A NURSE WAS TRYING TO PULL BLOOD FROM A CHILD AND WAS ONLY ABLE TO FILL 30-35CC WITH SEVERAL ATTEMPTS/SYRINGES. THE CLINICAL TEAM ALSO NOTED THAT THE FLANGE SEEMS DIFFERENT IN APPEARANCE AND FOR SOME REASON THERE IS A GREAT DEAL OF RESISTANCE WHEN YOU GO TO FIRST USE THE PRODUCT. THEY STATED THEY CANNOT COMPLETELY PULL OUT THE FLANGE TO RELEASE THE AIR LOCK AS THIS WOULD OPEN THE DEVICE FOR INFECTION. ADDITIONAL INFORMATION RECEIVED ON 5-MAR-2020 STATED THAT THE PATIENT WAS AN OPEN HEART PATIENT THAT NEEDED RAPID FLUID AND BLOOD RESUSCITATION TO PREVENT ARREST AND THEY WERE UNABLE TO USE THESE 60 ML MONOJECT SYRINGES TO RAPIDLY PUSH VOLUME OR BLOOD INTO THE PATIENT. SEVERAL RN, APN AND INTENSIVIST (MALE AND FEMALE) ATTEMPTED TO PUSH NS OR BLOOD INTO HIGH VOLUME TUBING INTO DISTAL PORTS OF CENTRAL LINE AND IT WAS NEARLY IMPOSSIBLE TO PUSH ANY OF THIS VOLUME OUT FOR DELIVERY TO THE PATIENT. THIS INCIDENT WAS NOT ON PUMPS. THEY WERE ALL MANUAL PUSHES. THE SYRINGES ARE VERY STICKY AND APPEAR TO BE LESS LUBRICATED OR TOO TIGHT FOR THE DIAMETER. WHEN THERE IS SOME SVR OR TUBING RESISTANCE THEY CANNOT GET THE PLUNGER TO PUSH FORWARD. THEY TRIED MULTIPLE SYRINGES

  Patient problems: Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 9922700 ↗
• InjuryApr 3, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT A NURSE WAS TRYING TO PULL BLOOD FROM A CHILD AND WAS ONLY ABLE TO FILL 30-35CC WITH SEVERAL ATTEMPTS/SYRINGES. THE CLINICAL TEAM ALSO NOTED THAT THE FLANGE SEEMS DIFFERENT IN APPEARANCE AND FOR SOME REASON THERE IS A GREAT DEAL OF RESISTANCE WHEN YOU GO TO FIRST USE THE PRODUCT. THEY STATED THEY CANNOT COMPLETELY PULL OUT THE FLANGE TO RELEASE THE AIR LOCK AS THIS WOULD OPEN THE DEVICE FOR INFECTION. ADDITIONAL INFORMATION RECEIVED ON 5-MAR-2020 STATED THAT THE PATIENT WAS AN OPEN HEART PATIENT THAT NEEDED RAPID FLUID AND BLOOD RESUSCITATION TO PREVENT ARREST AND THEY WERE UNABLE TO USE THESE 60 ML MONOJECT SYRINGES TO RAPIDLY PUSH VOLUME OR BLOOD INTO THE PATIENT. SEVERAL RN, APN AND INTENSIVIST (MALE AND FEMALE) ATTEMPTED TO PUSH NS OR BLOOD INTO HIGH VOLUME TUBING INTO DISTAL PORTS OF CENTRAL LINE AND IT WAS NEARLY IMPOSSIBLE TO PUSH ANY OF THIS VOLUME OUT FOR DELIVERY TO THE PATIENT. THIS INCIDENT WAS NOT ON PUMPS. THEY WERE ALL MANUAL PUSHES. THE SYRINGES ARE VERY STICKY AND APPEAR TO BE LESS LUBRICATED OR TOO TIGHT FOR THE DIAMETER. WHEN THERE IS SOME SVR OR TUBING RESISTANCE THEY CANNOT GET THE PLUNGER TO PUSH FORWARD. THEY TRIED MULTIPLE SYRINGES

  Patient problems: Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 9922698 ↗
• InjuryApr 3, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT A NURSE WAS TRYING TO PULL BLOOD FROM A CHILD AND WAS ONLY ABLE TO FILL 30CC. THE NURSE HAD TO SWITCH SYRINGES AND THE SECOND TIME WAS ONLY ABLE TO PULL 35CC. IN ONE INSTANCE THEY HAD TO SWITCH THE SYRINGE THREE TIMES WHICH SUBJECTS THE PATIENT TO MULTIPLE LEVELS OF INFECTION. THE CLINICAL TEAM ALSO NOTED THAT THE FLANGE SEEMS DIFFERENT IN APPEARANCE AND FOR SOME REASON THERE IS A GREAT DEAL OF RESISTANCE WHEN YOU GO TO FIRST USE THE PRODUCT. THEY STATED THAT THEY CANNOT COMPLETELY PULL OUT THE FLANGE TO RELEASE THE AIR LOCK AS THIS WOULD OPEN THE DEVICE FOR INFECTION. ADDITIONAL INFORMATION RECEIVED ON 5-MAR-2020 STATED THAT THE PATIENT WAS AN H1N1 PATIENT ON ECMO THAT NEEDED RAPID FLUID AND BLOOD RESUSCITATION TO PREVENT ARREST AND THEY WERE UNABLE TO USE THE 60 ML MONOJECT SYRINGES TO RAPIDLY PUSH VOLUME OR BLOOD INTO THE PATIENT. SEVERAL RN, APN AND INTENSIVIST (MALE AND FEMALE) ATTEMPTED TO PUSH NS OR BLOOD INTO HIGH VOLUME TUBING INTO DISTAL PORTS OF CENTRAL LINE AND IT WAS NEARLY IMPOSSIBLE TO PUSH ANY OF THIS VOLUME OUT FOR DELIVERY TO THE PATIENT. THIS INCIDENT WAS NOT ON PUMPS. THEY WERE ALL MANUAL PUSHES. THE SYRINGE IS VERY STICKY AND APPEARS

  Patient problems: Low Blood Pressure/ Hypotension; No Code Available

  MAUDE report 9922692 ↗
• MalfunctionMar 6, 2020Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  THE CUSTOMER REPORTED, A NURSE IN THE ICU FOUND THAT THE SYRINGE PLUNGER WAS LOOSE AND THAT THE PRODUCT LEAKED SOLUTION. THEY ALSO REPORTED WHEN THE SYRINGE IS INVERTED, THE SOLUTION FLOWS FREELY FROM THE TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9797768 ↗
• MalfunctionFeb 20, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE LUER TIP BREAKS OFF DURING MANIPULATION/COMPOUNDING. THIS HAPPENED DURING THE FILLING OF THE ON-Q PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732804 ↗
• MalfunctionFeb 20, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE LUER TIP BREAKS OFF DURING MANIPULATION DURING COMPOUNDING AND THE LUER LOCK TIP IS FLEXING WHEN USED WITH A CLOSED SYSTEM TRANSFER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732229 ↗
• MalfunctionFeb 18, 2020Fluid/Blood Leak; Structural Problem; Fluid/Blood Leak; Structural Problem

  THE CUSTOMER REPORTED THAT WHEN THE NURSE PULL BACK ON THE PLUNGER OF THE SYRINGE WHILE ON A NASOGASTRIC TUBE, THE STOMACH CONTENTS SPRAYED THROUGH THE BACK SIDE OF THE SYRINGE AND SPLASHED TO THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED ON 17-FEB-2020 STATING THAT THE PLUNGER SEEMS TO BE TOO SMALL FOR THE CANNULA AND THE SEAL WAS POOR. THE NURSE HAD A DIRECT SKIN EXPOSURE TO THE PATIENT'S STOMACH BILE. THE NURSE WAS NOT HARMED. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9722481 ↗