Monoject 1180325100Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Standard Hypodermic 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 10884521012431), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE DEVICE CAME APART AND EXPLODED THE MEDICATION ALL OVER THE PLACE. THE CUSTOMER STATED THAT THE NEEDLE SEPARATED FROM THE SYRINGE AND REMAINED INSIDE WHILE THE MEDICATION (TRT) SHOT OUT EVERYWHERE. ADDITIONAL INFORMATION RECEIVED ON 29FEB2024 STATED THAT THE PATIENT SELF-ADMINISTERS TESTOSTERONE REPLACEMENT THERAPY (TRT) SO THIS WAS A SELF INJECTION, INTRA-MUSCULAR. THE HUB AND NEEDLE REMAINED SECURELY ATTACHED TO EACH OTHER, BUT THE HUB SEPARATED FROM THE SYRINGE, THE MEDICATION WAS IMMEDIATELY PUSHED OUT OF THE SYRINGE. THE NEEDLE AND HUB (TOGETHER) REMAINED INSIDE THE PATIENT AND WAS PULLED FROM THE INJECTION SITE MANUALLY BY GRASPING THE HUB AND PULLING THE NEEDLE OUT. THERE WAS NO SIGNIFICANT INJURY, ONLY A FAILED INJECTION, WASTED MEDICATION (ONE DOSE), MILD PAIN AT INJECTION SITE, AND MINIMAL BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 18853050 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.