INTROCAN SAFETY® 4251621-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® Deep Access IV Catheters, 20GA, 2.5in. · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964825996), received between Apr 4, 2023 and Apr 21, 2026 — classified as 4 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
- Leak/Splash1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: DESCRIBE THE EVENT OR PROBLEM: NO HARM TO PATIENT. UPON PIV [PERIPHERAL IV] PLACEMENT, METAL NEEDLE DISLODGED FROM FLASH CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24938374 ↗MalfunctionDec 3, 2025Break; Break
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: BROKE OFF IN PATIENT, POTENTIAL INFECTION RISK. 3.5CM OF THE IV CATHETER WAS RETAINED IN THE PATIENT'S SKIN UPON REMOVAL OF THE DEVICE. THIS PATIENT THEN HAD TO BE TRANSPORTED TO A HIGHER ACUITY HOSPITAL TO HAVE THE REMAINING CATHETER SURGICALLY REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 23703987 ↗MalfunctionOct 9, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: DIFFICULTY ADVANCING THE CATHETER AND WHILE TROUBLESHOOTING WE NOTICED BLOOD COME OUT OF THE CATHETER DISTAL TO THE SKIN INSERTION SITE. WE REMOVED THE IV AND FLUSHED THE CATHETER AND FOUND MULTIPLE HOLES IN THE DEVICE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17895891 ↗MalfunctionApr 4, 2023Break; Break
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER RIPPED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16676365 ↗
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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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