BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY® 3

    MDR report key: 24049827 · Received January 12, 2026

    Report

    Report Number
    9610825-2025-00782
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 5, 2025
    Report Date
    January 15, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. 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 # K111236.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). COMPLAINT ANALYSIS: THE SITUATION DESCRIBE ON TWO OCCASIONS OVER THE PAST TWO WEEKS BROKEN AND SNAPPED. THAT IS, THE PLASTIC ON THE TUBE, A FEW CENTIMETERS FROM THE INSERTION POINT, HAS BENT TO THE EXTENT THAT IT CAME LOOSE, LEAVING A SMALL TIP IN THE PATIENT'S VEIN. THE PRODUCT WAS NOT SAVED. DEVICE HISTORY RECORD (DHR): UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS BATCH IS UNKNOWN. EVIDENCE AT DISPOSAL: NO SAMPLE RECEIVED BUT A PHOTO WAS PROVIDED FOR EVALUATION. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATIC ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS 100% INSPECTION ON THE CAPILLARY TIP. PRODUCT DETECTED OUT OF THE INSPECTION CRITERIA WILL BE REJECTED AUTOMATICALLY BY MACHINE. CONCLUSION: AS NO SAMPLE WAS RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "PERIPHERAL VENOUS CATHETER HAS ON TWO OCCASIONS OVER THE PAST TWO WEEKS BROKEN AND SNAPPED. THAT IS, THE PLASTIC ON THE TUBE, A FEW CENTIMETERS FROM THE INSERTION POINT, HAS BENT TO THE EXTENT THAT IT CAME LOOSE, LEAVING A SMALL TIP IN THE PATIENT'S VEIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107832 INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown