Kawasumi 23Gx3/4"12"Recalls & reported problems
Jiangsu Caina Medical Co.,Ltd · K-Shield Advantage® Winged Blood Collection Set with Multiple Sample Luer Adapter · Class 2
Data updated Oct 18, 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 06971564467964), received between Aug 13, 2025 and Aug 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ONE IS THAT THE SHEATH CAME OFF FROM THE NEEDLE AFTER THE PACKAGE WAS OPENED. THE OTHER IS THAT THE SHEATH DID NOT FULLY RECOVER AFTER INSERTING THE TUBE INTO THE SHEATH NEEDLE. THE CLINIC LAB MANAGER SAYS "THE RUBBER STOPPER WILL FALL OFF THE NEEDLE WHEN OPENING THE PACKAGE. THERE ARE TIMES WHERE THE RUBBER STOPPER DOES NOT COME BACK AND COVER THE NEEDLE WHEN THE TUBE IS DISENGAGED AND THERE IS A BLOODY MESS. THE DBMA BUTTERFLIES SEEMED EXTRA SHARP. BUT THIS IS NO LONGER TRUE OF THE CBMA."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22791276 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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