Monoject 8881520673Recalls & reported problems
Cardinal Health, Inc. · 20 mL Syringe Regular Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20884521012179), received between May 23, 2019 and Apr 26, 2024 — classified as 7 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.
Reports received per month
Most reported problems
Device problems
- Break5
- Device Contamination with Chemical or Other Material1
- Separation Problem1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2024Break; Break
THE CUSTOMER REPORTED THAT THERE HAS BEEN AN INSTANCE WHERE A SAFETY NEEDLE AND SYRINGE NEEDLE HAS BROKEN WHILE IN USE, CAUSING BLOOD TO COME IN CONTACT WITH THE NURSING STAFF. NO PRODUCT NUMBER OR FURTHER DETAILS WERE PROVIDED.
Patient problems: Exposure to Body Fluids
MAUDE report 19191646 ↗MalfunctionMay 1, 2023Break; Break
THE CUSTOMER REPORTED THAT UPON COMPLETION OF TREATMENT, THE TIP OF THE SYRINGE BROKE OFF IN THE PATIENT'S HD CATHETER. THE CLINICIAN, EDUCATOR AND NEPHROLOGIST ARE AWARE. THE TIP WAS FINALLY REMOVED WITH FORCEPS AND NO DAMAGE WAS SEEN TO THE CATHETER HUB. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16845101 ↗MalfunctionJan 24, 2023Break; Break
THE CUSTOMER REPORTED THE TIP IS BROKEN ON THE SYRINGES IN THE SEALED CASE. THEY FOUND SEVERAL IN THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16233137 ↗MalfunctionJun 14, 2021Separation Problem; Separation Problem
CUSTOMER REPORTS: THE TIP IS BENT ON THE SYRINGE. USER IS UNSURE WHICH LOT IT IS FROM. BY A VISUAL PHOTO OBSERVATION, IT IS APPARENT THAT THE TIP OF THE SYRINGE IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 11994079 ↗MalfunctionAug 28, 2020Break; Break
THE CUSTOMER REPORTED THAT THE STAFF NOTICED A BROKEN TIP OF A 20 ML SYRINGE BEFORE USING.
Patient problems: No Patient Involvement
MAUDE report 10464911 ↗MalfunctionFeb 21, 2020Break; Break
THE CUSTOMER REPORTED THAT THE LUER TIP OF THE SYRINGE BROKE OFF PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 9741620 ↗MalfunctionMay 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THE SYRINGES ARE COATED WITH A CLEAR AND STICKY SUBSTANCE IN THE PACKAGING AND INSIDE THE SYRINGE.
Patient problems: No Patient Involvement
MAUDE report 8636995 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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