Monoject 8881535101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20192253030737), received between Dec 8, 2022 and Dec 8, 2022 — classified as 2 malfunctions.

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

• 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. 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 15943422 ↗
• 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. 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 15943381 ↗