McKesson 200-IVRB201Recalls & reported problems
Mckesson Medical-Surgical Inc. · IV Catheter, Safety, Push button, Pink, 20G x 1" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10612479267968), received between Aug 5, 2025 and Jun 29, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (13 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
- Fail-Safe Problem13
- Difficult or Delayed Activation1
- Fail-Safe Did Not Operate1
- Improper or Incorrect Procedure or Method1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2026Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Fail-Safe Did Not Operate
CUSTOMER PROVIDED THE FOLLOWING DESCRIPTION: "THE SAFETY RETRACTION BUTTON IS NOT ALWAYS PULLING BACK THE NEEDLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659938 ↗MalfunctionDec 4, 2025Leak/Splash; Fail-Safe Problem; Leak/Splash; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT CATHETER APPEARS TO BE OCCLUDED CAUSING FORCE TO BE USED TO PUSH THE PLUNGER. THIS RESULTS IN LEAKAGE DUE TO THE PRESSURE USED. THE CUSTOMER ALSO REPORTED THAT THE NEEDLE DOESN'T RETRACT AFTER PUSHING THE BUTTON. 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 23719643 ↗MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE PROTRUDES FROM PLASTIC CASING. 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 23634397 ↗MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE NEEDLE IS NOT RETRACTING BACK AFTER PUSHING THE BUTTON, CAUSING LEAKING AT THE CATHETER SITE WHILE PERFORMING AN IV ON A PATIENT. 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 23631787 ↗MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE DOES NOT RETRACT AND REMAIN IN THE HUB. 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 23631286 ↗MalfunctionNov 24, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE PROTRUDES FROM THE SHAFT WHEN SAFETY BUTTON IS PUSHED. 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 23630731 ↗MalfunctionNov 21, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE IS PROTRUDING OUT AT THE BOTTOM. 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 23621736 ↗MalfunctionNov 21, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT STAY SECURED IN THE NEEDLE SHIELD. 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 23620053 ↗MalfunctionNov 20, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE PROTRUDES FROM THE END. 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 23609618 ↗MalfunctionNov 20, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE IS EXPOSED. 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 23605674 ↗MalfunctionOct 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOESN'T FULLY RETRACT AND STAYS EXTERNAL. IF YOU TIP THE NEEDLE UPSIDE DOWN AFTER RETRACTING IT, IT FALLS OUT. 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 23280609 ↗MalfunctionSep 17, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE PUSH BUTTON WAS FULLY DEPRESSED AND THE SPRING WAS COMPRESSED, NO SAFETY RETRACTION OCCURRED. 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 23072441 ↗MalfunctionSep 10, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOESN'T FULLY RETRACT, AND THE SAFETY BUTTON HAS TO BE PUSHED MULTIPLE TIMES BEFORE THE NEEDLE RETRACTS AT ALL. 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 23015130 ↗MalfunctionAug 5, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES DO NOT FULLY RETRACT. 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 22715834 ↗
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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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