Monoject 8881103066Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe Luer-Lock Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521030886), received between Mar 9, 2022 and Mar 9, 2022 — classified as 3 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
Device problems
- Fluid/Blood Leak3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING THE PERUSE CHECK, WHEN THE PHYSICIAN TRIED TO DRAW THE SALINE INTO 3CC SYRINGES FOR INFLATING THE BALLOON, THE LEAKAGE HAPPENED FROM THE SYRINGE. AS THE SYRINGE HAD CRACKED, IT WAS UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13716412 ↗MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT DURING THE PRE-USE CHECK, WHEN THE PHYSICIAN TRIED TO DRAW THE SALINE INTO 3CC SYRINGES FOR INFLATING THE BALLOON, LEAKAGE HAPPENED FROM THE SYRINGE. AS THE SYRINGE HAD CRACKED, IT WAS UNABLE TO USE. ANOTHER SYRINGE IN THE HOSPITAL INSTEAD WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13716208 ↗MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGE THAT GOES INTO THE COMMON CAROTID ARTERY HAS A CRACK. THE SURGEON NOTICED DURING THE PREOPERATIVE TEST, BUT THEY USED THE OTHER SYRINGE IN THE KIT. THE SHUNT WORKED. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2022 STATED THAT EACH THEIR F3 SHUNT KIT IS PACKAGED WITH TWO SYRINGES. THE FIRST SYRINGE LEAKED DURING THE PRE-USE CHECK WHEN THE USER ATTEMPTED TO INFLATE ONE OF THE BALLOONS OF THE PRUITT F3 SHUNT WITH SALINE TO CHECK THE BALLOON FUNCTIONALITY SO THEY USED THE SECOND SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13716172 ↗
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- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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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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