Monoject 1181815Recalls & 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 10884521544734), received between Sep 15, 2023 and May 16, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem1
- Fluid/Blood Leak1
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.
MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED: THE CUSTOMER REPORTED THAT WHENEVER THEY TRY TO INJECT IT INTO THE PATIENT IT IS LEAKING BLOOD AROUND THE TIP. THEY HAVE USED THEM 10 TIMES AND 3 OF THE 10 HAVE DONE THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035587 ↗MalfunctionSep 15, 2023Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE SAFETY PART OF THE NEEDLE BROKE AS SOON AS THE CLEAR CAP WAS TAKEN OFF THE NEEDLE. THIS HAPPENED MULTIPLE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17759180 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- 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.