BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APA

    MDR report key: 2211646 · Received August 5, 2011

    Report

    Report Number
    3006260740-2011-00267
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 13, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    DAMAGED CATHETER WAS FOUND. THE INDWELLING PERIOD WAS 42 DAYS. THE PRODUCT WAS USED AND MAINTAINED AT THE PATIENT HOME. HOWEVER, THE PATIENT IS VISUALLY IMPAIRED AND IT IS HIGHLY POSSIBLE THAT THE PATIENT UNKNOWINGLY FLUSHED THE LOOPED CATHETER, WHICH LED TO THE CATHETER DAMAGE. THE USER WOULD LIKE TO KNOW THE POSSIBLE CAUSE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROVIAC 4.2 FR SINGLE-LUMEN CV CATHETER PEEL-APA LJS C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention