BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG TPS 5F MAX

    MDR report key: 3902580 · Received May 9, 2014

    Report

    Report Number
    3006260740-2014-00245
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REYA2131 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    TWO PICC NURSES NOTICED THIS PATIENT HAD A LOT OF REDNESS (15CM X 15CM) AROUND THE INSERTION SITE. THEY PULLED THE PICC LINE AND NOTICED A FRACTURE IN THE CATHETER BETWEEN THE 2CM - 3CM MARK, CLOSER TO THE 3CM MARK. THEIR ASSUMPTIONIS THAT TOO MUCH PRESSURE WAS USED TO FLUSH THE PICC AS IT WAS NOTED "DIFFICULT TO FLUSH" AND THAT POTENTIALLY CAUSED THE CATHETER TO RUPTURE LEADING TO AN INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282281 POWERPICC SOLO HF CATHETER W/SHERLOCK 3CG TPS 5F MAX LJS BARD ACCESS SYSTEMS INC. REYA2131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention