Introcan Safety ® 2 4242006-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 2 IV Catheter - 20 Ga. x 1.0 in. · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Introcan IV catheter is a short-term catheter placed in a vein. The 59 reports describe brown material found inside the catheter hub, blood leaking because blood control did not work, and catheter tips breaking with pieces possibly left in patients, with no deaths and no injuries mentioned. No recalls name this device. Reports rose from 8 in the prior 12 months to 43 in the last 12 months.
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
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 04046955745944), received between Mar 25, 2024 and Mar 23, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (37 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
- Contamination /Decontamination Problem37
- Fail-Safe Problem12
- Break6
- Leak/Splash2
- Reflux within Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Needle Stick/Puncture7
- Foreign Body In Patient3
- Hemorrhage/Blood Loss/Bleeding2
- Exposure to Body Fluids1
- Pain1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Leak/Splash; Reflux within Device
AS REPORTED BY THE USER FACILITY: DURING TRIAL WITH SAMPLE PRODUCT, THE PRE-OP CHARGE NURSE STATES THAT WHEN THEY WITHDREW THE STYLET FROM THE HUB, BLOOD CAME OUT AS IF THERE WAS NO BLOOD CONTROL IN THE HUB. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24665389 ↗MalfunctionMar 3, 2026Break
AS REPORTED BY THE USER FACILITY: FAILED IV START; BLOOD DIDN'T ENTER VACUTAINER AND REMAINED IN EXTENSION TUBING. IV CATH REMOVED FROM PT ARM AND TIP OF PLASTIC NOT INTACT. MD UPDATED ORIGAMI FILED AS NOT SURE IF PLASTIC RIPPED OR IF A PIECE IS NOW EMBOLIZED AND INSIDE PT VASCULATURE. MANAGER UPDATED AND PRODUCT GIVEN TO MS (B)(6).
Patient problems: Foreign Body In Patient
MAUDE report 24498064 ↗MalfunctionFeb 20, 2026Break
AS REPORTED BY THE USER FACILITY: PATIENT ARRIVED, WHERE THEY HAD IV CATHETER PLACED. PATIENT WAS ADMITTED, THEN THE PATIENT WAS SEEN DAYS LATER AND DIAGNOSED WITH A RETAINED FRAGMENT OF THE IV CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 24400847 ↗MalfunctionFeb 11, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: BROWN SUBSTANCE IDENTIFIED IN CATHETER HUB. PATIENT INJURY: NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317553 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258762 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258761 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258758 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258757 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258756 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258729 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258728 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258727 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258726 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258725 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258415 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258399 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258389 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258387 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258386 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258385 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258365 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258334 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258321 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258319 ↗MalfunctionFeb 4, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, A BROWN SUBSTANCE IS PRESENT IN THE SAMPLE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258318 ↗
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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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