INTROCAN SAFETY® 3 4251130-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 3 Closed IV Catheter 20 Ga. x 1.25 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964014055), received between Apr 27, 2017 and Sep 12, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 Problem2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Difficult to Advance1
- Fail-Safe Problem1
- Leak/Splash1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture1
- No Information1
- Vasculitis1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Difficult to Advance; Fail-Safe Problem; Difficult to Advance; Fail-Safe Problem
ACCORDING TO THE EVENT DESCRIPTION THE CATHETER PASSIVE SAFETY MECHANISM DID NOT ENGAGE WHEN REMOVING STYLETTE FROM PATIENT , ANOTHER WAS DIFFICULT TO THREAD. THE SAFETY THAT IS SUPPOSED TO ENGAGE WHEN REMOVED FROM THE PLASTIC CATHETER HOUSING WHEN REMOVING THE NEEDLE FROM THE PATIENT FAILED TO COVER THE SHARP END OF THE NEEDLE ON MULTIPLE NEEDLES FROM THIS SAME LOT NUMBER. A THIRD WAS DIFFICULT TO ADVANCE THE PLASTIC CATHETER OFF THE NEEDLE INTO THE VEIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23036451 ↗MalfunctionAug 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION DEFECTIVE PRODUCT INTROCAN 3. DETAILED INQUIRY DESCRIPTION THERE WERE SEVERAL NEW INTROCAN 3 PRODUCTS WITH DEBRIS ON THE CATHETER. IT APPEARED TO BE EXTRA MATERIAL FROM THE MOLDING PROCESS. THEY THREW THEM ALL AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22715651 ↗MalfunctionMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE EVENT DESCRIPTION, "PATIENT INTER TO UCI WITH SEPTIC DISRUPTIVE SHOCK, TRI-VALVULAR INSUFFICIENCY, URINARY TRACT INFECTION AND RENAL FAILURE HAVE PHLEBITIS AT THE SITE OF THE PUNCTION."
Patient problems: Vasculitis
MAUDE report 22097266 ↗MalfunctionFeb 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IN RADIOLOGY DURING SCAN THEY WERE UNABLE TO FLUSH IV AND THOUGHT THERE WAS BLOCKAGE. THE NURSES HAD THE MD PUSH ON THE SYRINGE, AND HE WAS UNABLE TO. WHEN THEY PULLED BACK, THEY NOTICED SOME METAL COME INTO THE EXTENSION SET. NOTHING WAS SAVED NOR WERE ANY PICTURES TAKEN. THIS IV CATHETER IS NEW TO THEM, AND THEY THOUGHT THAT METAL WAS LEFT INSIDE THE HUB AFTER INSERTION. WE CONFIRMED HOW THE SAFETY MECHANISM WORK AND THAT IT WAS REMOVED DURING THE INITIAL IV INSERTION LEAVING NO METAL INSIDE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16277588 ↗MalfunctionAug 24, 2021Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACTICITY: CUSTOMER JUST CONVERTED TO INTROCAN SAFETY 3. NURSE PLACED A 20G IN PATIENT. WHEN THREADING, STARTED TO DO A PUSH/PULL TECHNIQUE, AS IS CUSTOM WITH THEIR PREVIOUS DEVICE. BBRAUN EDUCATOR SHOWED THAT SHE SHOULD HOLD THE HUB WITH LEFT HAND AND REMOVE THE STYLET STRAIGHT OUT WITH RIGHT HAND. BBRAUN EDUCATOR IMMEDIATELY NOTICED A SLIGHT BLOOD LEAK FROM HUB. BY THE TIME THE EXTENSION SET WAS PLACED THERE WAS A SMALL AMOUNT OF BLOOD COMING OUT OF THE HUB. EXTENSION SET WAS PLACED WITHOUT DIFFICULTY AND THE CATHETER FUNCTIONED CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12363625 ↗MalfunctionFeb 8, 2018Break; Break
AS REPORTED BY USER FACILITY: THE PATIENT WAS WINCING WHEN TRYING TO PLACE THE CATHETER. THE CATHETER WAS REMOVED AND IT WAS THEN NOTED THAT THE CATHETER HAD SHEARED IN THE MIDDLE. THE PATIENT WAS RESTUCK WITHOUT FURTHER INCIDENT.
Patient problems: Needle Stick/Puncture
MAUDE report 7251357 ↗MalfunctionApr 27, 2017Malposition of Device; Malposition of Device
AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINGDOM): PLASTIC TUBE WHICH SITS IN VEIN SNAPPED
Patient problems: No Information
MAUDE report 6525906 ↗
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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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