Introcan Safety ® 2 4232012-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety 2 - 18G x 1.25 in., PUR, Straight · Class 2
All models of Introcan Safety 2 (9)
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 04046955341979), received between Jan 6, 2023 and Jan 24, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fail-Safe 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.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: ISSUE: "THE IV CATH HAS SOME RESISTANCE WHEN SLIDING THE CATHETER END OUT FROM THE NEEDLE INTO THE PATIENT. IT HAS A DRAGGING FEEL TO IT, WHERE IT IS SUPPOSED TO BE SMOOTH. THE NURSES STARTED NOTICING THIS THIS WEEK. IT HAPPENS IN THE 18GA NEEDLE CATHETER." & "REPORTED TO ME THAT SHE USED AN 18 GAUGE IV TO FLUSH A WOUND. SHE REMOVED THE NEEDLE FROM THE CATHETER AND MET RESISTANCE. WHEN SHE WAS ABLE TO REMOVE THE NEEDLE FULLY THE CLIP THAT SHOULD BE ON THE END WAS STUCK HALFWAY UP THE NEEDLE AND THE NEEDLE TIP WAS EXPOSED. NO ONE WAS HARMED. LOT 22G21G827A UPON FURTHER INSPECTION OF CATHETERS, THERE ARE 2 18-GAUGE LOTS THAT HAVE MORE THAN NORMAL RESISTANCE WHEN SEPARATING THE NEEDLE FROM THE CATHETER. THESE WERE REMOVED FROM THE DEPARTMENT, PLACED IN THE MANAGER'S OFFICE. THE LOT CURRENTLY IN THE ER IS FUNCTIONING APPROPRIATELY ONLY 18 GAUGE FOUND TO HAVE ISSUES. THE OTHER LOT WITH RESISTANCE IS 22M04G8271."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21233459 ↗MalfunctionJan 6, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: UPON REMOVAL OF STYLET OUT OF THE HUB ONE OF THE SIDES OF THE PROTECTIVE SHIELD FELL OFF. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16115349 ↗
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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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