Monoject 8881520657 (UDI 20884521012155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521012155), received between Dec 14, 2020 and Jun 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT SYRINGES HAVE SCRATCHES ON THE SIDE WHICH IS CAUSING CRACKING AND THEY ARE LEAKING OUT FLUID. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841839 ↗
• MalfunctionFeb 1, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE TIP OF THE LUER LOCK IS MISSING AND THREADS ARE BENT. THE SYRINGE WAS FOUND BY THE NURSE WHEN THEY WENT TO TRY AND FILL WITH NORMAL SALINE. THE SYRINGE NEVER MADE IT TO PATIENT. THE ISSUE CAUSED MORE WORK FOR THE NURSE. THERE WAS NO CLINICAL SIGNIFICANCE NOR INJURY TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258872 ↗
• MalfunctionJan 22, 2021Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  PER CUSTOMER, THE PATIENT WAS IN TRAINING TO DO HEMODIALYSIS AT HOME. IN THE TRAINING ROOM, WHEN THE PATIENT HAS CONNECTED A BLUNT FILL NEEDLE TO THE SYRINGE TO DRAW NORMAL SALINE INTO SYRINGE, THERE WAS LEAKING NOTICED AROUND THE TIP. THE STAFF MEMBER WAS ASKED TO SEE THE SYRINGE AND AN ABNORMALITY IN THE SYRINGE WAS NOTICED. UPON LOOKING CLOSER, THE SYRINGE TIP WAS NOTED TO BE MISSING FROM THE INSIDE THREADS. THE PATIENT DID NOT USE THE PRODUCT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11216710 ↗
• MalfunctionDec 14, 2020Contamination; Contamination

  THE CUSTOMER REPORTED THAT WHEN THEY WERE MIXING THE DRUGS A SMALL PIECE OF PLASTIC WAS NOTICED INSIDE OF THE SYRINGE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003859 ↗