McKesson 2194Recalls & reported problems
Mckesson Medical-Surgical Inc. · COLLECTION SET, BLD W/SFTY SHL · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 20612479204281), received between Nov 11, 2019 and Nov 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2019Material Twisted/Bent; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THE NEEDLE BENDS WHEN THEY STICK PATIENTS. THE SAFETY FEATURE IS DIFFICULT TO CLOSE, AND BLOOD HAS GOTTEN ON THE STAFF NUMEROUS TIMES WHILE THEY ARE TRYING TO CLOSE IT. ADDITIONAL INFORMATION WAS RECEIVED 18OCTOBER2019: THEY FOUND IT WAS DIFFICULT TO "SNAP THE NEEDLE INTO THE SAFETY. IT WAS REPORTED THAT THERE WERE NO NEEDLE STICKS AND NO PATIENTS OR STAFF WERE INJURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9304050 ↗
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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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