Monoject 1181910Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
- 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 10884521544741), received between May 11, 2023 and May 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fail-Safe Problem1
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.
MalfunctionMay 11, 2023Fail-Safe Problem; Fail-Safe Problem
CUSTOMER REPORTS: THERE ARE PROBLEMS WITH THE NEW NEEDLES. STAFF ARE HAVING PROBLEMS WITH THEM DRAWING MEDS OUT OF VIALS. ALSO THE ENTIRE SAFETY DEVICE IS FALLING OFF IF THEY AREN¿T CAREFUL WITH THEM. THE SAFETY IS SNAPPING OFF WHEN ATTACHING NEEDLE TO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16914542 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.