INTROCAN SAFETY® 3 4251127-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 3 Closed IV Catheter 24 Ga. x 0.75 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY 3 (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964013997), received between Nov 16, 2023 and Sep 29, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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
- Leak/Splash4
- Contamination /Decontamination Problem1
Patient problems
- Chemical Exposure3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928021 ↗MalfunctionOct 2, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2 BRIEF INQUIRY DESCRIPTION MULTIPLE OCCURRENCES OF INTROCAN SAFETY 3 IV S LEAKING AT THE EXTENSION SITE CONNECTION DETAILED INQUIRY DESCRIPTION IVS LEAKED DURING CHEMO ADMINISTRATION AND MEDICATION SPILLED ONTO PATIENTS.
Patient problems: Chemical Exposure
MAUDE report 20355353 ↗MalfunctionOct 2, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3 BRIEF INQUIRY DESCRIPTION MULTIPLE OCCURRENCES OF INTROCAN SAFETY 3 IV S LEAKING AT THE EXTENSION SITE CONNECTION DETAILED INQUIRY DESCRIPTION IVS LEAKED DURING CHEMO ADMINISTRATION AND MEDICATION SPILLED ONTO PATIENTS.
Patient problems: Chemical Exposure
MAUDE report 20355309 ↗MalfunctionOct 2, 2024Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION MULTIPLE OCCURRENCES OF INTROCAN SAFETY 3 IV S LEAKING AT THE EXTENSION SITE CONNECTION DETAILED INQUIRY DESCRIPTION IVS LEAKED DURING CHEMO ADMINISTRATION AND MEDICATION SPILLED ONTO PATIENTS.
Patient problems: Chemical Exposure
MAUDE report 20355029 ↗MalfunctionNov 16, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CHEMO LEAK AT CATHETER-JLOOP CONNECTION. DETAILED INQUIRY DESCRIPTION: RN CALLED WITH CONCERN FOR CHEMO LEAK DURING IV INFUSION. SHE STATED IV HAD GOOD BLOOD RETURN AND SALINE FLUSH (VIA IV DRIP) INFUSED WITHOUT ISSUE. CHEMO WAS THEN STARTED VIA PUMP INFUSION. LEAK WAS IDENTIFIED AT CATHETER-JLOOP CONNECTION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18151503 ↗
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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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