Monoject 1182310Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · 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 10884521544673), received between Nov 10, 2020 and Nov 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
THE CUSTOMER REPORTED WHEN THE RN ATTACHED THE NEEDLE TO THE SYRINGE, THE BLUE SAFETY COVER TWISTED OFF A LITTLE WITH THE MOTION OF PUTTING THE NEEDLE ONTO THE SYRINGE. SHE THEN NOTICED THAT A TINY LEAK/DROP OF THE DRUG APPEARED WHEN ATTEMPTING TO INJECT THE DRUG SUBCUTANEOUSLY. ADMINISTRATION OF THE DRUG WAS HALTED AND ANOTHER NEEDLE WAS USED. THE RN THEN TESTED OTHER NEEDLES WITH SALINE AND SHE WAS ABLE TO REPEAT THE ISSUE WITH SEVERAL SAFETY CAPS IN A ROW BEFORE ENCOUNTERING ONE THAT WAS HARD TO BREAK. THERE WAS NO HARM TO PATIENTS OPERATING ROOM STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10817520 ↗
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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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