Monoject 1188100777 (UDI 10884521013704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521013704), received between Apr 12, 2021 and Jul 13, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGES WERE LEAKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160092 ↗
• MalfunctionApr 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE PLUNGERS GET STUCK DURING INJECTIONS AND THEY ARE HAVING TO DISCARD THE ENTIRE SYRINGE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON APRIL 13, 2021 STATED THAT THEY WERE REFERRED BY BOTH MEDLINE AND CARDINAL HEALTH TO USE THESE SYRINGES WHEN BD DISCONTINUED THE SYRINGES THEY WERE PREVIOUSLY USING WHEN DOING FAT GRAFTING. THE DOCTOR WAS WILLING TO GIVE THESE A TRY AS THEY WERE TOLD BY BOTH COMPANIES THAT THESE WOULD BE A SUITABLE REPLACEMENT BUT WHEN USING THEM, THE BLACK RUBBER STOPPER WOULD TURN SIDEWAYS WHEN PUSHING THE PLUNGER FORWARD. THEY TRIED USING CANNULAS TO REACH UP INSIDE THE BACK END OF THE SYRINGE TO STRAIGHTEN THE STOPPER AGAIN BUT IT WAS NOT WORKING WELL. THEY WASTED TONS OF FAT THEY HAD WORKED HARD TO RETRIEVE BECAUSE OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649362 ↗