BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 22770233 · Received August 11, 2025

    Report

    Report Number
    9610825-2025-00494
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 11, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE SITUATION DESCRIBED SOLUTION LEAKED FROM THE CATHETER INSERTION. WHEN THE CATHETER WAS REMOVED, IT RUPTURED, LEAVING THE SILICONE PORTION DETACHED AND REMAINING INSIDE THE PATIENT'S VEIN. THERE IS A POSSIBILITY THAT THE CATHETER COULD BE CUT OFF AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. NO SAMPLE RECEIVED AND NO PICTURE AVAILABLE FOR A PROPER EVALUATION. REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 24L17G8315 AND THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINE, THERE IS CATHETER TIP INSPECTION STATION AND CANNULA TIP INSPECTION STATION. DEFECTIVE PARTS WILL BE DETECTED BY THE VISION INSPECTION SYSTEM AND PARTS WILL BE REJECTED AUTOMATICALLY BY MACHINE. AS NO SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE. COMPLAINT IS NOT CONFIRMED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4) PREMARKET SUBMISSION #K020785.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "A PATIENT WITH PERIPHERAL VENOUS ACCESS IN THE UPPER LIMB (UL) UNDERWENT PERMEABILIZATION. SOLUTION LEAKED FROM THE CATHETER INSERTION. WHEN THE CATHETER WAS REMOVED, IT RUPTURED, LEAVING THE SILICONE PORTION DETACHED AND REMAINING INSIDE THE PATIENT'S VEIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109389 INTROCAN SAFETY® CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 24L17G8315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention