Monoject 8881501400Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Syringe Regular Tip · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521014053), received between Mar 3, 2020 and Jun 27, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance2
- Physical Resistance/Sticking2
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2023Difficult to Advance; Difficult to Advance
CUSTOMER REPORTED THAT THE PLUNGER DETACHES FROM THE STOPPER WHEN YOU PULL BACK AND WHEN YOU TRY TO INJECT IT IS EXTREMELY HARD TO PUSH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17213733 ↗MalfunctionAug 23, 2022Difficult to Advance; Difficult to Advance
CUSTOMER REPORTS: THE SYRINGE DOESN'T PLUNGE, MAKING IT DIFFICULT TO DRAW BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15275919 ↗MalfunctionMay 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THE PLUNGER IS VERY HARD TO MOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11889218 ↗MalfunctionMar 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED WHEN THE SYRINGE PLUNGER IS PULLED BACK, IT CANNOT BE DEPRESSED AFTERWARDS TO GIVE INJECTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11516802 ↗MalfunctionMar 3, 2020Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THE PLUNGERS ARE NOT AIR TIGHT AND AIR IS GETTING IN THE SYRINGES. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9779774 ↗
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- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.