INTROCAN SAFETY® 4251622-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® Deep Access IV Catheters, 22GA, 2.5in. · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964826023), received between Apr 11, 2019 and Jan 4, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS PER MEDWATCH REPORT # (B)(4): DESCRIBE THE EVENT OR PROBLEM: HEALTHCARE PROVIDER CALLED TO DO AN ULTRASOUND GUIDED PERIPHERAL INTRAVENOUS LINE (PIV) ON PATIENT WITH ARM RESTRICTION DUE TO PRESENCE OF ARTERIOVENOUS FISTULAS (AVF) ON LEFT ARM. INTROCAN SAFETY® DEEP ACCESS IV CATHETERS, 22GA, 2.5IN. ULTRASONOGRAPHY (USG) PIV PLACED TO RIGHT UPPER ARM. INSERTION WENT SMOOTHLY-FLASH TO BLOOD CHAMBER NOTED. AS SOON AS I TRIED TO SEPARATE CATHETER FROM NEEDLE, THE NEEDLE JUST CAME OFF FROM THE REST OF THE CATHETER. I WAS ABLE TO RETRIEVE REST OF NEEDLE FROM INSERTION SITE THEN SAFETY DEVICE WAS ENGAGED. NEEDLE IS ALL INTACT, DID NOT APPEAR BENT OR FRACTURED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PLACEMENT OF ULTRASOUND GUIDED PERIPHERAL INTRAVENOUS LINE (PIV) WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443414 ↗MalfunctionSep 12, 2022Break; Break
AS PER MEDWATCH NUMBER: MW0513190000-2022-8006. DESCRIPTION: A NURSE WAS ATTEMPTING TO INSERT AN IV CATHETER. SHE WAS ABLE TO SUCCESSFULLY INSERT THE CATHETER WITH POSITIVE BLOOD RETURN VISUALIZED. HOWEVER, WHEN SHE WAS WITHDRAWING THE METAL GUIDEWIRE, IT DETACHED FROM THE PLASTIC HUB IN HER FINGERS. APPROXIMATELY 1/2 INCH OF THE GUIDEWIRE WAS VISIBLE, AND SHE WAS ABLE TO GRAB THE WIRE AND WITHDRAW IT FROM THE PATIENT'S ARM WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15401169 ↗MalfunctionApr 11, 2019Break; Break
AS REPORTED BY USER FACILITY: THE CATHETER COMPLETELY DETACHED FROM THE HUB WAS IN THE PATIENT'S VEIN.
Patient problems: Foreign Body In Patient
MAUDE report 8503501 ↗
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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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