BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR TL POWERPICC MAX TRAY, TLS

    MDR report key: 2901728 · Received January 4, 2013

    Report

    Report Number
    3006260740-2013-00019
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 18, 2012
    Report Date
    December 12, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K053501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWF1904 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    STAFF UNABLE TO OBTAIN A BLOOD SPECIMEN FROM THE PICC LINE. RIGHT UPPER EXTREMITY SWELLING NOTED FROM INSERTION SITE TO PT'S NECK. PICC LINE WAS REMOVED AND LINE WAS NOTED TO BE TORN IN TWO SEPARATE LOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4366 5 FR TL POWERPICC MAX TRAY, TLS LJS C. R. BARD INC. (BASD) REWF1904

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention