Monoject 1183500777 (UDI 10884521010826)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521010826), received between Dec 19, 2019 and Dec 23, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2021Break; Break

  THE CUSTOMER REPORTED THAT A PHARMACY TECHNICIAN HAD A MEDICATION SPLASHED IN HER FACE DUE TO LUER TIP BREAK ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE TIP BROKE AND RESULTED IN SPLASHING OF HAZARDOUS DRUG DOXIL (DOXORUBICIN LIPOSOMAL) INTO THE EMPLOYEE'S RIGHT EYE. THE TECHNICIAN WAS IMMEDIATELY REPORTED TO EMPLOYEE HEALTH, WAS THEN SENT TO ADVENT HEALTH EMERGENCY ROOM (ER). ALSO, THE FOLLOWING WEEK THE EMPLOYEE WAS SENT TO BE OBSERVED BY AN OPTOMETRIST. NO EVIDENCE OF DAMAGE WAS DETECTED. THE EMPLOYEE HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2021.

  Patient problems: Chemical Exposure

  MAUDE report 13082867 ↗
• MalfunctionJun 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE PHARMACY TEAM HAS BEEN SEEING ISSUES ON THEIR ICU MED SPIROS PRODUCT LEAKING WHEN USING WITH THE MONOJECT SYRINGES. IN REVIEWING THE PRODUCTS AND FAILED DEVICES, THE CLINICAL TEAM NOTICED THAT THE LUER LOCK TIP ON THE MONOJECT SYRINGES HAS SHORTENED AND THE PACKAGING HAS CHANGED FROM WHAT THEY ARE USED TO SEEING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913019 ↗
• MalfunctionMay 25, 2021Material Opacification; Material Opacification

  THE CUSTOMER REPORTED THEY CONTINUE TO SEE CLOUDINESS AND A MARKED DIFFERENCE IN THE PLASTIC OF THE 35ML SYRINGES. THEY ARE CURRENTLY EXPERIENCING 75% REJECTION RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876685 ↗
• MalfunctionMay 25, 2021Material Opacification; Material Opacification

  THE CUSTOMER REPORTED THEY CONTINUE TO SEE CLOUDINESS AND A MARKED DIFFERENCE IN THE PLASTIC OF THE 35ML SYRINGES. THEY ARE CURRENTLY EXPERIENCING 75% REJECTION RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876600 ↗
• MalfunctionApr 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CUSTOMER REPORTS: SYRINGES WERE FOUND WITH DEBRIS AND FIBER INSIDE, AND ON THE PLUNGER. SYRINGE ALSO HAD A BLUE COLOR INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702291 ↗
• MalfunctionAug 28, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE CUSTOMER STATES THAT THE IV TEACH WAS USING THE SYRINGES AND NOTICED A WHITE RESIDUE/SUBSTANCE ON THE INSIDE OF THE BARREL. THE TECH SAID ONE SYRINGE LOOKED LIKE IT HAD A BLACK HAIR ON IT ALSO. POSSIBLE LOTS 922459X OR 921043X.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465412 ↗
• InjuryJun 3, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TIP OF A FENTANYL PCA SYRINGE WAS BROKEN OFF INSIDE THE PCA TUBING. THE PATIENT WAS REQUIRED TITRATING UP OTHER SEDATION GTTS ON PREVIOUS SHIFT. THIS SYRINGE WAS NOT PREFILLED BY CARDINAL HEALTH. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT ADDITIONAL DOSES OF ANTI-HYPERTENSIVES WERE ALSO GIVEN BECAUSE OF THE LACK OF SEDATION. THEY ALSO STATED THAT THERE WAS LEAKING, HOWEVER, THE PROPOFOL WAS BACKING UP INTO THE FENTANYL INFUSION TUBING AND IT TOOK MULTIPLE HOURS TO FINALLY FIGURE OUT IT WAS LEAKING AS THE FENTANYL WAS GOING AT A VERY SLOW ML/HR RATE AND IT WAS NOT OBVIOUS THAT THERE WAS A LEAK. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: High Blood Pressure/ Hypertension; No Information

  MAUDE report 10116598 ↗
• MalfunctionApr 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007280 ↗
• 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 9996166 ↗
• MalfunctionDec 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT THE PLUNGERS ARE STICKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492410 ↗