Monoject 8881570121Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521000261), received between Nov 20, 2018 and Jun 14, 2021 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (16 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2021Infusion or Flow Problem; Air/Gas in Device; Infusion or Flow Problem; Air/Gas in Device

  CUSTOMER REPORTS: THE PLUNGER SLIDES BACK WAY TOO EASILY, DE-PRIMING THE SYRINGE, ALLOWING IT TO FILL WITH AIR IF CONSTANT PRESSURE IS NOT ON THE PLUNGER. ONCE THE CAP IS REMOVED AND THE SMALL AIR BUBBLE REMOVED, THE NURSE HAS TO KEEP POSITIVE PRESSURE ON THE PLUNGER AS SHE¿S CONNECTING TO THE IV. ADDITIONAL INFORMATION WAS PROVIDED THAT AIR HAS BEEN INTRODUCED INTO THE FLUID AND THAT IT OCCURS IMMEDIATELY WHEN THE SYRINGE IS HELD UPRIGHT. THERE HAS NOT BEEN ANY HARM TO A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11992176 ↗
• MalfunctionJun 7, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER STATES THAT AFTER PURGING AIR FROM THE SYRINGE, THE PLUNGER IS NOTED TO AUTONOMOUSLY RETRACT BACKWARDS DRAWING AIR BACK INTO THE SYRINGE. WHEN USED TO PRIME IV TUBING PRIOR TO STARTING A PIV, THE PLUNGER IS NOTED TO RETRACT FAR ENOUGH TO DRAW AIR ALL THE WAY BACK THROUGH THE SHORT IV EXTENSION TUBING AS WELL AS INTO THE SYRINGE. THE CUSTOMER IS USING MONOJECT 0.9% SODIUM CHLORIDE FLUSH SYRINGE (10ML).

  Patient problems: Insufficient Information

  MAUDE report 11949931 ↗
• MalfunctionMay 14, 2021Component Incompatible; Fluid/Blood Leak; Component Incompatible; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE SYRINGES DO NOT HAVE A VACUUM SEAL AND THE FLUID LEAKS OUT OF THEM. IN ADDITION, THE LABEL/STICKER IS NOT ON STRAIGHT SO THE LINES ARE CROOKED. THE ISSUES WERE DISCOVERED BEFORE PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829338 ↗
• MalfunctionMay 10, 2021Backflow; Air/Gas in Device; Backflow; Air/Gas in Device

  THE CUSTOMER REPORTED THAT WHEN USING THIS FLUSH TO PRIME AN IV PIGTAIL CATHETER PRIOR TO INSERTING AN IV, THE SYRINGE SUCKS THE SALINE BACK INTO THE SYRINGE AND WHEN THE SYRINGE IS USED FOR FLUSHING, THE AIR IS SQUIRTED OUT OF THE SYRINGE AND AS SOON AS THEY LET GO OF THE PLUNGER, AIR COMES BACK INTO THE SYRINGE. THE ISSUES WERE DISCOVERED BEFORE PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802312 ↗
• MalfunctionApr 7, 2021Air/Gas in Device; Air/Gas in Device

  CUSTOMER REPORTS: THE PREFILL SYRINGE HAS AIR POCKETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11629884 ↗
• MalfunctionMar 29, 2021Contamination; Contamination

  THE CUSTOMER REPORTED THAT THE SOLUTION WAS HAZY AND THE INSTRUCTIONS STATE NOT TO USE THE PRODUCT IF SOLUTION IS HAZY OR CLOUDY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585768 ↗
• MalfunctionFeb 18, 2021Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER STATED THAT THEIR STAFF IS HAVING DIFFICULTY EXTRACTING THE BUBBLE OF AIR. PER STAFF, THE BUBBLE OF AIR RETURNS, UNLESS THEY CONTINUE TO APPLY PRESSURE. THE CUSTOMER FURTHER STATED THEY GOT A SYRINGE SAMPLE AND NOTICED THAT IT APPEARS THAT WHEN THEY GET AN AIR BUBBLE OUT, THAT THE PLUNGER CONSISTENTLY MOVES BACKWARD PULLING AIR BACK INTO THE SYRINGE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11344335 ↗
• MalfunctionJan 20, 2021Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE PREFILL SYRINGE IS NOT STEADY. THE SYRINGE IS ADDING AIR IN THE DEAD SPACE AND CAUSING POTENTIAL PATIENT ISSUES. THE CUSTOMER ALSO STATED THAT WHEN THE PLUNGER IS PUSHED BACK, IT MOVES SLOWLY ON IT'S OWN CAUSING FLUID TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205609 ↗
• MalfunctionDec 17, 2020Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THEY ARE HAVING ISSUES WITH THE IV FLUSH SYRINGES ¿FREE FALLING¿ WHEN POSITIVE PRESSURE IS REMOVED RESULTING IN THE POSSIBILITY OF BACK FLOW OR AIR BEING INADVERTENTLY INSTILLED INTO THE IV TUBING. ADDITIONAL INFORMATION STATED THAT THE ISSUES WERE FOUND PRIOR TO PATIENT USE. IT WAS ALSO STATED THAT THE CUSTOMER'S ISSUE IS REGARDING THE POTENTIAL RISK OF AIR BEING INTRODUCED INTO THE SYRINGE OR LINE; IT DID NOT ACTUALLY OCCUR. ON 23-NOV-2020 THE SUPPLIER CONFIRMED THAT DURING FUNCTIONAL EVALUATION OF THE RETURNED DEVICE, THE SYRINGES WERE OPENED, AND THE AIR WAS PUSHED OUTSIDE EACH SYRINGE BEFORE LETTING GO OF THE PLUNGER. THE PLUNGER THEN RECEDED BACK INTO THE BARREL LETTING AIR INSIDE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028930 ↗
• MalfunctionOct 29, 2020Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED AFTER PUSHING THE SODIUM CHLORIDE INTO THE EXTENSION SET, THE SODIUM CHLORIDE SUCKS BACK OUT OF THE EXTENSION SET ALONG WITH A SMALL AMOUNT OF AIR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10756385 ↗
• MalfunctionAug 25, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PRIME TUBING WITH THE FLUSH, IF THEY DO NOT HOLD THE PLUNGER OR CLAMP THE TUBING IT BACKS UP WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448253 ↗
• MalfunctionAug 25, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PRIME TUBING WITH THE FLUSH, IF THEY DO NOT HOLD THE PLUNGER OR CLAMP THE TUBING IT BACKS UP WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10448242 ↗
• MalfunctionJul 29, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT WHEN THEY FLUSH AIR OUT, THE SYRINGE PULLS BACK AND DRAWS IN A SMALL AMOUNT OF AIR AGAIN. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10341800 ↗
• MalfunctionJun 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTS: WHEN YOU FLUSH THE AIR OUT, THE SYRINGE PULLS BACK AND DRAWS IN A SMALL AMOUNT OF AIR AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10207161 ↗
• MalfunctionJun 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTS: WHEN YOU FLUSH THE AIR OUT, THE SYRINGE PULLS BACK AND DRAWS IN A SMALL AMOUNT OF AIR AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10207124 ↗
• MalfunctionJun 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTS: WHEN YOU FLUSH THE AIR OUT, THE SYRINGE PULLS BACK AND DRAWS IN A SMALL AMOUNT OF AIR AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10207065 ↗
• MalfunctionJun 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTS: WHEN YOU FLUSH THE AIR OUT, THE SYRINGE PULLS BACK AND DRAWS IN A SMALL AMOUNT OF AIR AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10207020 ↗
• MalfunctionMar 4, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTS THAT THE EMT STATED THAT HE ROUTINELY AFFIXES THE FLUSH SYRINGE TO THE EXTENSION SETS TO PREPARE THEM FOR IV STARTS. HE THEN DEPRESSES THE PLUNGER ROD TO PRIME THE SYSTEM WITH SALINE, BUT HAS OBSERVED THAT AFTER THE EXTENSION SET HAS BEEN VISUALLY CONFIRMED TO BE FILLED WITH SALINE THE SOLUTION SPONTANEOUSLY RETURNS TO THE SYRINGE WHILE LYING UNDISTURBED ON COUNTERTOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9786762 ↗
• MalfunctionMar 2, 2020Fitting Problem; Infusion or Flow Problem; Fitting Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT ONCE THE PLUNGER ROD HAS BEEN DEPRESSED TO EXPEL THE AIR BUBBLE, THE PLUNGER TIP RETREATS TOWARD ITS ORIGINAL LOCATION, DRAWING AIR BACK INTO THE SYRINGE. THEY ALSO MENTIONED THAT CONSTANT THUMB PRESSURE MUST BE MAINTAINED TO PREVENT THIS MOVEMENT OF THE PLUNGER UNLESS IT IS ADVANCED TO ABOUT THE 9ML MARKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775916 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE SYRINGE HAD NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE. THE NURSE FLUSHED THE EXTENSION TUBING ONLY TO FIND THAT THE FLUID SHE PREVIOUSLY PLACED INTO THE J LOOP WITHDREW INTO THE SYRINGE, THEREFORE THE EXTENSION TUBING WAS FILLED WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766026 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE SYRINGE HAD NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE. THE NURSE FLUSHED THE EXTENSION TUBING ONLY TO FIND THAT THE FLUID SHE PREVIOUSLY PLACED INTO THE J LOOP WITHDREW INTO THE SYRINGE, THEREFORE THE EXTENSION TUBING WAS FILLED WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765980 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE SYRINGE HAD NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE. THE NURSE FLUSHED THE EXTENSION TUBING ONLY TO FIND THAT THE FLUID SHE PREVIOUSLY PLACED INTO THE J LOOP WITHDREW INTO THE SYRINGE, THEREFOR THE EXTENSION TUBING WAS FILLED WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765414 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE SYRINGE HAD NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE. THE NURSE FLUSHED THE EXTENSION TUBING ONLY TO FIND THAT THE FLUID SHE PREVIOUSLY PLACED INTO THE J LOOP WITHDREW INTO THE SYRINGE, THEREFOR THE EXTENSION TUBING WAS FILLED WITH AIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765404 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THE DEVICE WAS NOTICED TO HAVE NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE WHEN THE USER REMOVES PRESSURE FROM THE END OF THE SYRINGE. THIS WAS DISCOVERED DURING SET UP AFTER A NURSE FOUND THE ISSUE WHILE FLUSHING AN EXTENSION TUBING AND THE FLUID RETURNED TO THE SYRINGE LEAVING THE TUBE AIR FILLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764528 ↗
• MalfunctionFeb 27, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THE DEVICE WAS NOTICED TO HAVE NEGATIVE PRESSURE WHICH DRAWS THE FLUID BACK INTO THE SYRINGE WHEN THE USER REMOVES PRESSURE FROM THE END OF THE SYRINGE. THIS WAS DISCOVERED DURING SET UP AFTER A NURSE FOUND THE ISSUE WHILE FLUSHING AN EXTENSION TUBING AND THE FLUID RETURNED TO THE SYRINGE LEAVING THE TUBE AIR FILLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764430 ↗