Monoject 1188822112Recalls & reported problems
Cardinal Health, Inc. · Standard Hypodermic Needle,Polypropylene Hub · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521007161), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PATIENT WAS IN CLINIC FOR A DUROLANE INJECTION. THIS IS A PRE-FILLED SYRINGE OF MEDICATION FROM PHARMACY. DOCTOR APPLYING A 22GX1.5 INCH NEEDLE BY SCREWING IT ONTO THE SYRINGE. IT DID NOT STAY ATTACHED AND THE MEDICATION EXPLODED OUT THE SYRINGE. THEY HAD TO REPLACE THE NEEDLE AND GET NEW MEDICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852526 ↗
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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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