INTROCAN SAFETY® 4253574-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 20 Ga. x 1 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963318260), received between Apr 3, 2019 and Apr 3, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Protective Measures 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 16, 2026.
Most reported problems
Device problems
- Protective Measures Problem2
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: SAFETY MECHANISM WAS NOT ACTIVATED. NURSE RECEIVED NEEDLESTICK INJURY.
Patient problems: Needle Stick/Puncture
MAUDE report 8479611 ↗MalfunctionApr 3, 2019Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: SAFETY MECHANISM WAS NOT ACTIVATED. NURSE RECEIVED NEEDLESTICK INJURY.
Patient problems: Needle Stick/Puncture
MAUDE report 8479607 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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