Monoject 1186000777T (UDI 10884521189645)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521189645), received between Dec 30, 2019 and Aug 18, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT PIECES OF THE INNER LUMEN BROKE OFF WHEN THEY WERE PRIMING THE HEART AND LUNG MACHINE FOR USE. THE PATIENT AT THE TIME WAS UNSTABLE AND DECLINING. PER ADDITIONAL INFORMATION RECEIVED, THE BROKEN LOCATION WAS AT THE LUER LOCK TIP. THERE WAS NO MEDICAL INTERVENTION REQUIRED, HOWEVER IT OCCURRED DURING AN EMERGENT SITUATION AND CAUSED A DELAY. THE PATIENT IS CURRENTLY DECEASED. PER ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE WAS AN AORTIC VALVE REPLACEMENT RE-DO. THE DELAY LASTED MINUTES AND IT IS UNLIKELY THAT IT LED TO THE DEATH. IT IS ALSO UNLIKELY THAT THERE WAS A CORRELATION BETWEEN THE DEVICE AND THE DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576982 ↗
• MalfunctionJan 4, 2022Break; Break

  THE CUSTOMER REPORTED THAT THEY HAVE HAD AN EMPLOYEE HEALTH CASE OCCURRED DUE TO THE SYRINGE BREAKING AND SHOOTING INTO SOMEONE¿S EYE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE SYRINGE BROKE AT THE LUER TIP. THE INCIDENT HAPPENED DURING A DIFFERENT STEP OF MIXING. THE MEDICATION USED DURING THE INCIDENT WAS NOT INDICATED. THE CUSTOMER FURTHER STATED THAT THERE WAS NO HARM OCCURRED TO THE STAFF INVOLVED AND THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13151740 ↗
• MalfunctionDec 17, 2021Break; Break

  PER CUSTOMER, A PHARMACY TECHNICIAN STATED THAT SHE HAS EXPERIENCED LUER TIP BREAK ISSUE WITH A 60ML SYRINGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE TIP BROKE WHILE MIXING, HOWEVER THIS INCIDENT OCCURRED DURING A DIFFERENT STAGE OF MIXING. THERE WAS NO HARM OCCURRED DURING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13031893 ↗
• MalfunctionMay 6, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE TIPS OF THE SYRINGE BROKE OFF WHEN ATTACHING THEM TO PGA PUMPS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783311 ↗
• MalfunctionJul 24, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE CLINICIAN TURNED IN A 60ML SYRINGE THAT THEY BELIEVED HAD SOME PARTICULATE INSIDE OF IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323712 ↗
• MalfunctionJul 6, 2020Component or Accessory Incompatibility; Component or Accessory Incompatibility

  THE CUSTOMER REPORTED THAT MEDICATION CAN ESCAPE THE SYRINGE THROUGH THE PLUNGER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237537 ↗
• MalfunctionApr 28, 2020Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT REMOVING MINUTE AIR BUBBLES WAS DIFFICULT AND HARD TO MEASURE ACCURACY. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007532 ↗
• MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE DEVICE WAS LEAKING THROUGH THE RUBBER STOPPER ON THE PLUNGER, WHILE MIXING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007304 ↗
• MalfunctionApr 27, 2020Break

  THE CUSTOMER REPORTED THAT THE SYRINGE TIP WAS BREAKING OFF FROM THE VIAL ADAPTERS WHILE MIXING CHEMO INSIDE THE CHEMO DRUG PREPARATION SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000891 ↗
• MalfunctionApr 24, 2020Illegible Information; Illegible Information

  THE CUSTOMER REPORTED THAT IT WAS DIFFICULT TO READ THE MEASUREMENTS ON THE SYRINGE. THE LINES ARE EXTREMELY CLOSE TOGETHER AND BARELY VISIBLE TO THE CAMERA VERIFICATION SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996395 ↗
• MalfunctionMar 9, 2020Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT THE 60ML SYRINGE IS REPORTEDLY SPONTANEOUSLY DETACHING FROM THE 4-WAY STOPCOCKS. THE CUSTOMER FURTHER STATED THAT THE PHYSICIAN HAD EXPERIENCED DIFFICULTY ATTACHING THE SYRINGE TO THE FEMALE LUER OF THE STOPCOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806569 ↗
• MalfunctionDec 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE SYRINGE POPS OFF THE INJECTOR AS THE PATIENT IS BEING INJECTED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530130 ↗