Monoject 1183005Recalls & 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 10884521544789), received between Jul 14, 2021 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (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
- Dull, Blunt1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt
"THE CUSTOMER REPORTED THAT PATIENTS WERE COMPLAINING OF PAIN WHEN INJECTING THE NEEDLE."
Patient problems: Pain
MAUDE report 22035498 ↗MalfunctionJul 14, 2021Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NURSE PRACTITIONER WAS INJECTING THE PATIENT WITH BOTOX WHEN THE NEEDLE ATTACHED TO THE BOTOX SYRINGE MALFUNCTIONED, CAUSING BOTOX TO SQUIRT OUT AROUND THE HUB OF THE NEEDLE, RESULTING IN THE LOSS OF BOTOX AND BOTOX GOING TO PATIENT'S EYE. NURSING CONTACTED THE PHARMACY AND OPTOMETRY AND WASHED OUT PATIENT'S EYE PER THEIR RECOMMENDATION. AN EXTRA 50 UNITS OF BOTOX HAD TO BE DRAWN UP TO REPLACE THE BOTOX THAT WAS LOST. 25 UNITS WERE LOST. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE PATIENT'S EYE WAS WASHED OUT WITH SALINE AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165794 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.