Monoject 1182734Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521544772), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE SAFETY NEEDLES ARE PROVING TO HAVE SAFETY ISSUES AS THEY HAVE THE POTENTIAL TO STICK THE USER WHEN COVERING THE NEEDLE WITH THE SAFETY DEVICE. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 AND (B)(6) 2021, STATED THAT THE DEVICE DID NOT MALFUNCTION. THE NURSE HAD PREVIOUSLY USED SLIDE SAFETY MECHANISMS AND HAD NEVER USED THIS PRODUCT BEFORE. WHEN SHE USED HER THUMB TO PUSH DOWN THE SAFETY WHILE HOLDING AN INFANT IN HER OTHER HAND, HER THUMB SLIPPED OFF OF THE SAFETY TO THE SIDE AND SHE WAS STUCK BY THE NEEDLE. THIS OCCURRED AFTER SHE HAD USED THE NEEDLE FOR AN INFANT INJECTION. THERE IS NO INFORMATION AVAILABLE REGARDING ANY MEDICAL INTERVENTION REQUIRED FOR THE NURSE OR ANY POTENTIAL FOLLOW UP CARE THAT MAY BE REQUIRED.
Patient problems: Needle Stick/Puncture
MAUDE report 11304959 ↗
Other Needle, hypodermic, single lumen devices
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- 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 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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