McKesson 200-IVSB221Recalls & reported problems
Mckesson Medical-Surgical Inc. · IV Catheter, Safety, Sliding, with Blood control, 22G x 1" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10612479268262), received between Jun 12, 2025 and Aug 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER WAS LEAKING SALINE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852723 ↗MalfunctionJul 18, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT ON TWO OCCASIONS THE CATHETERS LEAKED. NO OTHER INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22540394 ↗MalfunctionJun 12, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER CAP WAS NOT FULLY SECURED INSIDE THE PACKAGING, AND BOTH THE NEEDLE AND CATHETER APPEARED BENT UPON INSPECTION. IN ANOTHER INCIDENT, THE NEEDLE AND CATHETER BEGAN TO BEND IMMEDIATELY UPON INSERTION INTO THE SKIN, EVEN BEFORE ANY ADVANCEMENT. THE DEVICE WAS PROMPTLY RETRACTED TO PREVENT POTENTIAL HARM TO THE PATIENT. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194575 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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