BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING

    MDR report key: 3181989 · Received June 17, 2013

    Report

    Report Number
    3006260740-2013-00302
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    LINE FRACTURE. NO SPECIFIC DETAILS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274197 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention