Introcan Safety 2Recalls & reported problems across all models

We found 9 models of Introcan Safety 2 by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 102 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2022 and Mar 26, 2026 — classified as 1 injury, 101 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (54 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Introcan Safety 2 problems

Introcan Safety 2 models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Introcan Safety ® 2 4242006-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  57 reports
• Introcan Safety ® 2 4242004-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  15 reports
• Introcan Safety ® 2 4232006-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  9 reports
• Introcan Safety ® 2 4242012-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  9 reports
• Introcan Safety ® 2 4242008-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  6 reports
• Introcan Safety ® 2 4232004-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  2 reports
• Introcan Safety ® 2 4232012-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  2 reports
• Introcan Safety ® 2 4232005-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report
• Introcan Safety ® 2 4232008-02

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report

Recent Introcan Safety 2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: EMAIL RECEIVED: "WE RECEIVED A REPORT THAT ON (B)(6) 2026, AN RN ON THE FOURTH FLOOR AT TRADITION HOSPITAL COMPLETED IV INSERTION WITH CATALOG 4242004-02, LOT#25M02G8B05. THE SAFETY HAD MALFUNCTIONED AND WAS NOT FULLY ENGAGED/NOT COVERING NEEDLE RESULTING IN A NEEDLE STICK INJURY WHILE CLEANING UP THEIR WORKSPACE. TO MY KNOWLEDGE, THE SAMPLE WAS NOT SAVED." NEEDLESTICK INJURY WITH IS2. PATIENT INJURY NO.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24697914 ↗
• 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 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: THE INTERNAL FLANGE CAME OUT WITH THE STYLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498020 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: CUSTOMER STATED, "WHEN DR. (B)(6) WAS PLACING B. BRAUN INTROCAN SAFETY 2 IV (18G X 1.25") IN PATIENT AND PULLED BACK NEEDLE, PIECE OF THE OVER NEEDLE CANULA CAME OFF WITH THE SAFETY DEVICE." PATIENT INJURY: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497920 ↗
• 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 11, 2026Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: THE RN SUCCESSFULLY STARTED TWO SEPARATE IVS AND THE INTROCAN SAFETY 2 BLOOD CONTROL MECHANISM FAILED TO STOP THE BLOOD FROM FLOWING OUT OF THE HUB. THEY HAD TO CHANGE THE LINENS, AND THE NURSE WAS EXPOSED TO BLOOD. THE DATES AND TIMES ARE NOT CLEAR AS SHE REPORTED IT OCCURRED TWICE DURING THE PAST WEEK. THERE ARE NO SAMPLES ASIDE FROM THE PACKAGING OF ONE IV. PATIENT INJURY: NO.

  Patient problems: Exposure to Body Fluids; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24317336 ↗
• MalfunctionFeb 5, 2026Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE COMPLAINANT, THE IS2 CATHETER LEAKED BLOOD ALL OVER THE DRESSING AND OTHER SUPPLIES IN THE KIT. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24271705 ↗
• 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 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls