Monoject 8303SARecalls & reported problems
Cardinal Health, Inc. · Monoject Sharps Container, Transportable, Red, 1 Quart · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521023666), received between Jun 8, 2021 and Jun 30, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).
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
- Material Puncture/Hole2
Patient problems
- Needle Stick/Puncture2
- Exposure to Body Fluids1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2021Material Puncture/Hole; Material Puncture/Hole
CUSTOMER REPORTS: A NEEDLE POKED THROUGH THE SIDE OF THE CONTAINER AT SOME POINT EVENTUALLY CAUSING SOMEONE TO RECEIVE A FINGER STICK. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE NEEDLE STICK WAS FROM A CONTAMINATED NEEDLE.
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 12091959 ↗InjuryJun 8, 2021Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THAT THE SHARPS CONTAINER USED IN THE EMS SETTING ALLOWED FOR A NEEDLE TO PIERCE THE SIDE OF THE CONTAINER, CAUSING AN UNPROTECTED EXPOSURE/NEEDLE STICK. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Needle Stick/Puncture
MAUDE report 11957369 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.