Monoject 1182315Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
- 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 10884521544666), received between May 24, 2019 and Jan 12, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 13236837 ↗MalfunctionMay 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER STATED THE NEEDLE FELL OFF THE SYRINGE AS THEY WERE MOVING IT FROM THE PATIENT TO THE KIDNEY DISH. DUE TO THE WEIGHT OF THE SAFETY COVER, IT FELL WITH THE NEEDLE FACING UPWARDS. A STAFF MEMBER ATTEMPTED TO COVER THE NEEDLE AND SUFFERED A SHARPS INJURY TO THE THUMB IN THE PROCESS. THE NEEDLE WAS DISPOSED OF AS PER SHARPS DISPOSAL PROCESS. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THE CUSTOMER HAS COMPLETED THEIR INTERNAL INVESTIGATION INTO THE INCIDENT. ON REFLECTION, THE INJURED COLLEAGUE FEELS THAT IT IS LIKELY THAT SHE HADN¿T CONSTRUCTED THE SYRINGE PROPERLY AND THIS WAS THE CAUSE OF THE FAILURE.
Patient problems: Needle Stick/Puncture
MAUDE report 8640224 ↗
Other Needle, hypodermic, single lumen devices
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- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.