Monoject 1182000777 (UDI 10192253034677)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10192253034677), received between Dec 8, 2022 and Apr 12, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Dec 28, 2023Open, Classified

   Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

   Z-0855-2024 · Root cause: Process change control · FDA record ↗

2. Sep 20, 2023Open, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0148-2024 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT THEIR HOSPITAL USES MONOJECT SYRINGES. THE REPORTER STATED THAT MONOJECT SYRINGES WERE PREVIOUSLY MANUFACTURED BY COVIDIEN. THEY HAVE RECENTLY CHANGED TO CARDINAL HEALTH. CARDINAL HEALTH IS USING THE SAME REFERENCE NUMBER AND MONOJECT NAME, BUT THE SYRINGES ARE DIFFERENT. THE REASON THIS IS AN ISSUE IS BECAUSE THEIR HOSPITAL USES THE MONOJECT SYRINGES ON THEIR MEDFUSION PUMPS. THE MEDFUSION PUMPS ARE PROGRAMMED WITH THE PARAMETERS OF THE SYRINGE. NOW, WHEN THEY PUT THE MONOJECT SYRINGE ON THE MEDFUSION PUMP, IT CANNOT BE RECOGNIZED. THEY HAVE REPORTED THIS ISSUE TO CARDINAL HEALTH BUT NO RESOLUTION YET. THE REPORTER STATED THAT THEY ARE CONCERNED BECAUSE HOSPITALS ACROSS THE COUNTRY USE MEDFUSION SYRINGE PUMPS AND WHEN THEY GO TO RUN A POTENTIALLY LIFE SUSTAINING MEDICATION WITH A CARDINAL HEALTH MONOJECT SYRINGE IT WILL NOT WORK ON THE SYRINGE PUMPS. IT SEEMS THAT CARDINAL HEALTH SHOULD NOTIFY ALL OF ITS CUSTOMERS OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095253 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED A COMPATIBILITY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095231 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED ANONYMOUSLY BY HEALTH SCIENCE UNIV THAT THE CARDINAL HEALTH MONOJECT 20ML REF: 118200777 SYRINGE IS "SLIGHTLY DIFFERENT" COMPARED TO THE COVIDIEN MONOJECT 20ML SYRINGE REF: 118200777. IT WAS NOTED THAT THE CARDINAL HEALTH MONOJECT 20ML SYRINGE CANNOT BE DETECTED BY THE SYRINGE PUMP. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095209 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THE SYRINGES DO NO WORK WITH THEIR ALARIS SYRINGE MODULES. THEY ARE GETTING ERROR MESSAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095082 ↗
• MalfunctionApr 12, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THE MONOJECT SYRINGES THAT ARE USED FOR THE ANESTHESIA SYRINGE PUMPS, HAVE CHANGED AND IT IS AFFECTING THE ABILITY OF THE SYRINGE PUMP TO RECOGNIZE IT. IN THE PICTURES ATTACHED, THE COVIDIEN MONOJECT IS ON THE LEFT AND THE CARDINAL HEALTH MONOJECT ON THE RIGHT. THE CARDINAL HEALTH MONOJECT NO LONGER WORKS WITH THE PUMP. ONCE THE PACKAGE IS OPEN THE STAFF CANNOT TELL THEM APART BECAUSE COVIDIEN OR CARDINAL HEALTH IS NOT WRITTEN ON THE SYRINGE TO IDENTIFY IT. THE CARDINAL HEALTH VERSION HAS A WIDER FLANGE AT THE BASE. THE NEW VERSION OF THE SYRINGE DOES NOT ALLOW FOR PROPER CALIBRATION OF THE SYRINGE PUMP AND MAY LEAD TO INACCURATE DOSING OF ANESTHETIC DRUGS. BD AND MONOJECT SYRINGES ARE THE ONLY ONES APPROVED FOR THE OR DUE TO COMPATIBILITY WITH THE ANESTHESIA SYRINGE PUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095080 ↗
• MalfunctionApr 11, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THEY NOTICED THAT THE SYRINGES HAVE THE SAME REF #, HOWEVER ARE CARDINAL BRANDED PACKAGING. THE PLUNGER ON THE CARDINAL BRAND ARE A LITTLE BIT LARGER AND THIS IS CAUSING THE INFUSION PUMPS TO REFUSE THE SYRINGE UNLESS THEY ARE "APPROVED" FOR USE IN THE INFUSION PUMPS. THE CUSTOMER IS ASKING IF WE HAVE DOCUMENTATION OR INFORMATION THAT THESE SYRINGES ARE APPROVED FOR USE IN THE INFUSION PUMPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094158 ↗
• MalfunctionApr 11, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THE SYRINGE DOES NOT FIT CONNECTION FOR MEDFUSION PUMP. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094157 ↗
• MalfunctionSep 5, 2023

  OUR HOSPITAL USES MONOJECT SYRINGES. MONOJECT SYRINGES WERE PREVIOUSLY MANUFACTURED BY COVIDIEN. THEY HAVE RECENTLY CHANGED TO CARDINAL HEALTH. CARDINAL HEALTH IS USING THE SAME REFERENCE NUMBER AND MONOJECT NAME BUT THE SYRINGES ARE DIFFERENT. THE REASON THIS IS AN ISSUE IS BECAUSE WE USE THE MONOJECT SYRINGES ON OUR MEDFUSION PUMPS. THE MEDFUSION PUMPS ARE PROGRAMMED WITH THE PARAMETERS OF THE SYRINGE. NOW, WHEN YOU PUT YOUR MONOJECT SYRINGE ON THE MEDFUSION PUMP IT CAN'T BE RECOGNIZED. WE HAVE REPORTED THIS ISSUE TO CARDINAL HEALTH BUT NO RESOLUTION YET. I AM CONCERNED BECAUSE HOSPITALS ACROSS THE COUNTRY USE MEDFUSION SYRINGE PUMPS AND WHEN THEY GO TO RUN A POTENTIALLY LIFE SUSTAINING MEDICATION WITH A CARDINAL HEALTH MONOJECT SYRINGE IT WILL NOT WORK ON THE SYRINGE PUMPS. IT SEEMS THAT CARDINAL HEALTH SHOULD NOTIFY ALL OF IT'S CUSTOMERS OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17691889 ↗
• MalfunctionDec 8, 2022Break; Break

  THE CUSTOMER REPORTED THE 35ML LUER LOCK TIPS ARE BREAKING. SOME IN PIECES AND SOME COMPLETELY AT THE CONNECTION TO THE SYRINGE BARREL. THE PROBLEM HAS CAUSED MEDICATION WASTE. PER ADDITIONAL INFORMATION PROVIDED ON DECEMBER 07, 2022, THE MEDICATION USED AT THE TIME OF THE BREAKS IS VARIABLE BUT MOST COMMONLY IS CEFAZOLIN, CEFTRIAXONE, OR CEFEPIME. THERE HAS BEEN NO PATIENT OR USER HARM ASSOCIATED WITH THE BREAKS. THEY USE B BRAUN¿S RED TAMPER EVIDENT CAP TO CAP THESE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942841 ↗