Monoject 1182110Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521544628), received between Jan 12, 2022 and Jul 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED THAT THEY WERE HAVING ISSUES WITH THIS NEEDLE LEAKING. WHEN THEIR LAB WAS DRAWING BLOOD, THE BLOOD STARTS RUNNING OUT THE SIDE OF THE NEEDLE DOWN THE PATIENT'S ARM. THE CUSTOMER ALSO STATED THAT THIS IS ALSO HAPPENING WITH MEDICATION BEING ADMINISTERED TO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574109 ↗MalfunctionJan 12, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE STAFF MEMBERS STATED THAT WHEN THE SAFETY DEVICE IS ACTIVATED, IT DOES NOT SEAL THE END OF THE NEEDLE SO BLOOD IS LEAKING OUT OF THE NEEDLE BEFORE THEY CAN REMOVE THE NEEDLE FROM THE SYRINGE. THE STAFFS ALSO REPORTED THAT THEY ARE HAVING MORE PROBLEMS ACCESSING THE VEINS WITH THESE NEEDLES UNLESS THE VEIN IS HUGE, RESULTING IN MULTIPLE STICKS TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE NEEDLE DIDN'T NOT SEEM TO PIERCE THE SKIN AS EASILY AS OTHER PRODUCTS. PER STAFF MEMBERS, THE NEEDLES ARE FLIMSY AND BEND EASILY, MAKING IT MORE DIFFICULT TO ACCESS THE VEIN. THE CUSTOMER ITSELF EXPERIENCED THIS ISSUE WHEN SHE PERFORMED A HAND STICK LAST WEEK. THE CUSTOMER FURTHER STATED THAT ACTIVATION OF THE SHIELD IS NOT A PROBLEM, THE PROBLEM IS AFTER IT IS ACTIVATED, THE NEEDLES LEAK. THE ACTIVATION PERFORMS AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13236862 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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