Introcan Safety ® 2 4242008-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® 2 IV Catheter - 20 Ga. x 1.25 in. · Class 2
All models of Introcan Safety 2 (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046955746026), received between Nov 19, 2024 and Feb 3, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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
- Contamination /Decontamination Problem3
- Break2
- Fail-Safe Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient1
- Needle Stick/Puncture1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, MULTIPLE CATHETERS WERE OBSERVED TO HAVE EXCESSIVE OIL IN THE HUB. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245493 ↗MalfunctionFeb 3, 2026Contamination /Decontamination Problem
ACCORDING TO THE COMPLAINANT, MULTIPLE CATHETERS WERE OBSERVED TO HAVE EXCESSIVE OIL IN THE HUB. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245414 ↗MalfunctionNov 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: WE HAVE SOME 20 GA IV CATHETERS (4248008-02), WE ARE BEING TOLD THAT LOT# 25F04G8276 HAS A STICKY SUBSTANCE ON THE TIP OF THE NEEDLES AND A PORTION OF THE SHAFT INSIDE THE STERILE PACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593825 ↗MalfunctionOct 22, 2025Break; Break
AS REPORTED BY THE MEDWATCH MW5175566 REPORT: DESCRIBE EVENT OR PROBLEM: THE METAL NEEDLE DISLODGED FROM THE PLASTIC PART YOU HOLD WITH YOUR HAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358122 ↗MalfunctionAug 26, 2025Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION SAFETY SHIELD BENT CAUSING STYLET TO BECOME STUCK IN THE HUB DETAILED INQUIRY DESCRIPTION PT HERE FOR CT IV, I STARTED AN IV FOR PT PROCEDURE. AS I ADVANCED THE CANULA AND RETRACTED THE NEEDLE THE SAFETY COVER THAT COVERS THE TIP OF THE NEEDLE BECAME STUCK TO THE INSIDE OF THE CANULA. I WAS UNABLE TO RETRACT THE NEEDLE, I HAD TO REMOVE THE ENTIRE CANULA TO ALSO REMOVE THE NEEDLE. DUE TO FAULTY EQUIPMENT I HAD TO START A SECOND IV FOR PT TO HAVE HER SCHEDULED PROCEDURE.
Patient problems: Needle Stick/Puncture
MAUDE report 22894967 ↗InjuryNov 19, 2024Break; Break
ACCORDING TO THE EVENT DESCRIPTION: WHEN REMOVING THE VENOUS CATHETER, THE NURSE NOTICED THAT THE CATHETER WAS BROKEN. A PIECE OF THE CATHETER WAS STUCK IN THE VEIN. REPORTEDLY THERE WAS SIGNIFICANT DIFFICULTY IN REMOVING THE PIECE OF CATHETER REMAINING IN THE VEIN. THE FRAGMENT WAS REMOVED WITH CLAMP.
Patient problems: Foreign Body In Patient
MAUDE report 20728131 ↗
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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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