Introcan Safety ® 2 4232005-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety 2 - 22G x 1.0 in., PUR, Winged · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955341870), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION PROVIDER STARTED IV, DID NOT REMOVE STYLET, JUST REMOVED THE VENTED FLASH PLUG DETAILED INQUIRY DESCRIPTION "THERE WAS AN EVENT ON ONE OF OUR UNITS WHERE AN NP INSERTED AN IV [IS2M] AND INADVERTENTLY REMOVED THE FLASHBACK (VENTED) PLUG WITHOUT WITHDRAWING THE NEEDLE FROM THE PATIENT'S ARM. THIS OCCURRED IN AN EMERGENCY SITUATION AND WASN'T RECOGNIZED IMMEDIATELY. WHEN THE PATIENT BEGAN TO COMPLAIN OF PAIN, IT WAS DISCOVERED THAT THE NEEDLE WAS STILL IN PLACE. THE NURSE MANAGER CONFIRMED THIS, AND THE SITUATION HAS SINCE BEEN RESOLVED."
Patient problems: Pain
MAUDE report 22737414 ↗
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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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