INTROCAN SAFETY® 4252511-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 24 Ga. x 0.55 in., FEP, Straight, Notched · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318161), received between Feb 13, 2019 and Aug 25, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): "BLOOD LEAKING WHERE CATHETER ATTACHES TO HUB. DEFECTIVE IV CATHETER - IV CATHETER WAS INSERTED INTO VEIN - IMMEDIATE FLASHBACK CONFIRMING POSITION OF CATHETER IN VEIN HOWEVER BLOOD BEGAN LEAKING WHERE CATHETER CONNECTS WITH HUB CAUSING INABILITY TO OBTAIN BLOODWORK AND USE CATHETER FOR IV. RESULTED IN LOSS OF IV FOR AN INFANT WITH VERY FEW SITES WHO WAS REQUIRING IMMEDIATE BLOODWORK." INCIDENT DATE UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22888500 ↗MalfunctionMar 1, 2019Break; Break
AS REPORTED ON MEDWATCH MW5083288: PREMATURE BABY AT (B)(6) WEEKS GESTATION WAS RECEIVING IV FLUIDS, THE CATHETER WAS PLACED ON (B)(6) 2019 AT 2210, WAS LEAKING ON (B) (6) 2019. WHEN IT WAS EVALUATED TO BE REMOVED. THE CATHETER DID NOT COME OUT. THE PART UNDER THE SKIN BROKE AND WAS REMOVED INTACT. NO PART OF THE CATHETER WAS RETAINED. ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY: THE RETAINED PIECE OF CATHETER WAS REMOVED AT THE BEDSIDE, AND NO ADDITIONAL TREATMENT OR SURGERY WAS REQUIRED.
Patient problems: Foreign Body In Patient
MAUDE report 8383329 ↗MalfunctionFeb 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: AFTER SUCCESSFUL IV INSERTION, BLOOD AND FLUID WERE LEAKING AROUND THE PLASTIC CATHETER AND HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8335748 ↗
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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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