McKeeson 16-BC2134Recalls & reported problems
Mckesson Medical-Surgical Inc. · COLLECTION SET, BLD SAFETY LUE · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20612479206070), received between Mar 10, 2023 and May 15, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (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.
Reports received per month
Most reported problems
Device problems
- Protective Measures Problem2
- Detachment of Device or Device Component1
- Fail-Safe Did Not Operate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2026Protective Measures Problem
SAFETY SPLITS INTO TWO HALVES- THE NEEDLES POPS BACK OUT. - UNSURE IF INJURY OR MEDICAL ATTENTION WAS NEEDED AT THIS TIME.
Patient problems: Needle Stick/Puncture
MAUDE report 25193575 ↗MalfunctionJul 11, 2025Detachment of Device or Device Component; Protective Measures Problem; Detachment of Device or Device Component; Protective Measures Problem
DURING REMOVAL OF THE BUTTERFLY NEEDLE, THE YELLOW COMPONENT, THAT COVERS THE NEEDLE AFTER USE, DETACHED UNEXPECTEDLY, RESULTING IN THE NEEDLE NO LONGER BEING COVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22480364 ↗MalfunctionMar 10, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
CUSTOMER FILED FDA MED WATCH REPORT BACK IN DEC 2021. MCKESSON QA WAS OFFICIALLY NOTIFIED ON SEPT 1ST 2022. I HAVE BEEN TRYING TO GET A PRODUCTION ACCOUTN SINCE OCT 2022. RECEIVED PRODUCTION ACCOUNT 3/8/23. SAFETY DID NOT PROPERLY ENGAGE AFTER IT CLICKED, RESULTING TO NEEDLE STICK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16522288 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.