Monoject 8881540101Recalls & reported problems
Cardinal Health, Inc. · Blunt Tip Needle,I.V. Access · 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 10884521082915), received between Jul 8, 2020 and Jul 8, 2020 — 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.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2020Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT THE RADIOLOGY DEPARTMENT RECEIVES PREFILLED SYRINGES FROM THE NUCLEAR MEDICINE DEPARTMENT. WHEN THE RADIOLOGY TEAM TRIES TO INJECT THROUGH THE "RUBBER HUB" (IV ACCESS BLUNT TIP), IT COMES LOOSE AND SUBSTANCE COMES OUT OF THE SYRINGE CAUSING RADIO CONTAMINATION.
Patient problems: No Information
MAUDE report 10248090 ↗
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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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