Monoject 1180100777 (UDI 10192253034530)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253034530), received between Apr 11, 2024 and Apr 14, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 reports).

3 FDA recall records name this device's identifier, 3 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-0851-2024 · Root cause: Process change control · FDA record ↗

2. Sep 20, 2023Open, Classified

   Demonstrated recognition and compatibility issues with syringe infusion pumps.

   Z-0145-2024 · Root cause: Vendor change control · FDA record ↗

3. Sep 13, 2023Open, Classified

   Syringe contains conical tip that is not compatible with certain needleless IV connector(s).

   Z-0112-2024 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORT THAT SYRINGE LEAKS, MORE PAINFUL INJECTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102916 ↗
• MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT AIR BUBBLES ARE NOT EASILY DISCHARGED (NEW PLUNGER STRUCTURE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102796 ↗
• MalfunctionApr 11, 2024Compatibility Problem; Compatibility Problem

  THE CUSTOMER REPORTED THAT THEY RECEIVED SOME FUNNY-LOOKING TB SYRINGES WITH AN EXTENDED BLACK PLUNGER TIP THAT LOOKS LIKE THE TIP OF A SHARPIE. THE INCORRECT ITEM CAUSED SOME ISSUES IN THEIR CARDIAC AREA WITH THEM NOT BEING ABLE TO FULLY INFUSE MEDICATIONS. PHOTOS ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 09AUG2023 STATED THAT THERE WAS NO INJURY TO THE PATIENT BUT DID RESULT IN A DELAY IN MEDICATION ADMINISTRATION. NO INTERVENTIONS WERE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094159 ↗
• MalfunctionApr 11, 2024Compatibility Problem; Compatibility Problem

  GRADUATED LINES ARE NOT EASILY RECOGNIZED (NEW PLUNGER STRUCTURE) LOTS OF AIR BUBBLES PUMP COMPATIBILITY ISSUES, NOT RECOGNIZED BY INFUSION PUMPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094156 ↗