Introcan Safety ® 2 4232004-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety 2 - 22G x 1.0 in., PUR, Straight · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955341856), received between Nov 23, 2022 and May 16, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2024Break; Break
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: POTENTIAL CATHETER SHEARING. DETAILED INQUIRY DESCRIPTION: MICHAEL CAMPOS SHARED WITH US ON A TEAMS CALL ABOUT POSSIBLE CATHETER SHEARING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19330307 ↗MalfunctionNov 23, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER WHO RECENTLY CONVERTED FROM IS STANDARD TO IS2 REREPORTED THAT IS STANDARD WAS STOCKED FOR THEM BY ACCIDENT IN PLACE OF IS2. THE CLINICIAN PICKED UP THE PRODUCT AND PROCEEDED TO USE THINKING SHE WAS USING BC. THIS RESULTED IN AN UNEXPECTED BLOODY MESS AS SHE WAS NOT EXPECTING THE HUB TO BLEED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15853878 ↗
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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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