McKesson 200-IVRB221Recalls & reported problems
Mckesson Medical-Surgical Inc. · IV Catheter, Safety, Push button, Blue, 22G x 1" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This McKesson push-button IV catheter is a short-term device used to start an IV. Reports mostly describe the catheter sticking during insertion and the retractable needle failing to pull back, with some leaks and one needlestick to a nurse. There are 30 reports naming its identifier, with no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10612479268026), received between Apr 24, 2025 and Apr 29, 2026 — classified as 1 injury, 25 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (24 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem24
- Leak/Splash3
- Fail-Safe Did Not Operate1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Physical Resistance/Sticking; Fail-Safe Did Not Operate
THE CATHETER STICKS WHEN ADVANCING THE CATHETER/STRAW OFF THE NEEDLE DURING IV START. THE CATHETER ALSO STICKS WHEN THE NEEDLE RETRACTION BUTTON IS PRESSED, WHICH HAS LED TO TWO PRIMARY CONCERNS: 1. THE FORCE OF THE RETRACTION CAN PULL THE CATHETER OUT OF THE VEIN, REQUIRING THE PATIENT TO UNDERGO A SECOND IV INSERTION. 2. IN SOME CASES, THE NEEDLE DOES NOT RETRACT, REQUIRING THE CLINICIAN TO MANUALLY REMOVE THE NEEDLE, WHICH INCREASES THE RISK OF ACCIDENTAL NEEDLE STICK OR EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25036043 ↗InjuryFeb 13, 2026Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER STUCK A NURSE DURING DISENGAGEMENT OF THE NEEDLE.
Patient problems: Needle Stick/Puncture
MAUDE report 24331829 ↗MalfunctionFeb 4, 2026Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER WAS LEAKING NEAR THE INJECTION SITE, ONCE THEY INJECT IT INTO PATIENTS. 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 24257831 ↗MalfunctionDec 10, 2025Leak/Splash; Fail-Safe Problem; Leak/Splash; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE 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 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 23767443 ↗MalfunctionDec 4, 2025Leak/Splash; Fail-Safe Problem; Leak/Splash; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE 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 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 23719814 ↗MalfunctionNov 17, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT FULLY RETRACT AFTER USE. 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 23569202 ↗MalfunctionSep 17, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT NEEDLES DO NOT STAY RETRACTED AFTER USE IF TILTED SLIGHTLY. 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 23075031 ↗MalfunctionSep 3, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE TIP IS STICKING OUT ONCE RETRACTED. 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 22955335 ↗MalfunctionAug 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT AFTER PUSHING THE BUTTON FOR RETRACTION, THE NEEDLE STICKS 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 22819401 ↗MalfunctionAug 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT AFTER THE SAFETY HAS BEEN ENGAGED, THE NEEDLE STICKS 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 22818465 ↗MalfunctionJul 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE IS STILL RETRACTING BUT THE NEEDLE STILL HANGS OUT. 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 22646698 ↗MalfunctionJul 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE PROTRUDED WHEN THE DEVICE WAS TURNED UPSIDE DOWN AFTER RETRACTION. 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 22645368 ↗MalfunctionJul 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT EXPERIENCED A FAULTY SAFETY MECHANISM. 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 22645069 ↗MalfunctionJul 23, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT RETRACT AND STAY IN THE BARREL. THE NEEDLE HANGS 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 22575758 ↗MalfunctionJul 18, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT RETRACT AND STAY IN THE BARREL. THE NEEDLE HANGS 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 22541290 ↗MalfunctionJun 30, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOES NOT RETRACT ALL THE WAY BACK . 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 22358367 ↗MalfunctionJun 13, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE PROTRUDED WHEN THE DEVICE WAS TURNED UPSIDE DOWN AFTER RETRACTION. 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 22204539 ↗MalfunctionJun 4, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLES ARE NOT RETRACTING. 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 22144237 ↗MalfunctionJun 4, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE COMES OUT OF THE PLASTIC HUB AFTER IT IS RETRACTED. 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 22140315 ↗MalfunctionMay 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT ALTHOUGH THE NEEDLE INITIALLY RETRACTS AS EXPECTED BY USING THE RETRACTABLE SAFETY MECHANISM AFTER USE; IT RE-EMERGES WHEN THE DEVICE IS POSITIONED UPRIGHT. THIS MALFUNCTION PRESENTS A POTENTIAL RISK OF NEEDLESTICK. 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 22105586 ↗MalfunctionMay 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THERE IS DIFFICULTY IN RETRACTING THE NEEDLE. 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 22104505 ↗MalfunctionMay 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE RETRACTS BUT DOESN'T STAY IN PLACE. 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 22104351 ↗MalfunctionMay 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER HAVING DIFFICULTY RETRACTING THE NEEDLE AND EVEN AFTER RETRACTION, THE NEEDLE COMES THROUGH OUTSIDE OF THE RESERVOIR. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESUT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029406 ↗MalfunctionMay 15, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE BUTTON IS PUSHED TO RETRACT THE NEEDLE IT DOES SO BUT THEN DOES NOT KEEP THE NEEDLE RETRACTED. THE NEEDLES MOVES IN AND OUT. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESUT OF THIS PRODUCT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028348 ↗MalfunctionApr 29, 2025Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED BY THE CUSTOMER THAT AFTER THEY INJECT THE PATIENT, THE NEEDLE RETRACTS BUT THEN MOVES OUT OF THE RETRACTION & IS EXPOSED. 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 21927472 ↗
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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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