BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINE 5 FR S/L MI W/SCUFF

    MDR report key: 9598348 · Received January 16, 2020

    Report

    Report Number
    3006260740-2020-00163
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741036583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE TWO COMPLAINTS, BOTH LOT NUMBERS WERE PROVIDED, AND LOT HISTORY REVIEWS WERE PERFORMED. OF THE 2 REPORTED MALFUNCTIONS, NO DEVICES WERE RETURNED FOR EVALUATION. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICES WERE LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 700515.CHRONIC CATHETER ALLEGEDLY EXPERIENCED PEELED. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58482 POWERLINE 5 FR S/L MI W/SCUFF CHRONIC CATHETER LJS BARD ACCESS SYSTEMS 0700515 RECX0807 00801741036583

    Patients

    Seq Age Sex Outcome Treatment
    1