BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 6 FR D/L MI W/SCUFF

    MDR report key: 9960431 · Received April 14, 2020

    Report

    Report Number
    3006260740-2020-01291
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE REPORTED EVENT, LOT NUMBER WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE WAS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0700615 CHRONIC CATHETER ALLEGEDLY EXPERIENCE FRACTURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422011 POWERLINE 6 FR D/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700615 REDU3536 00801741036606

    Patients

    Seq Age Sex Outcome Treatment
    1