BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION

    MDR report key: 1936039 · Received December 13, 2010

    Report

    Report Number
    3006260740-2010-00375
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 7, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K053501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME FOR EVAL. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    XRAY CONFIRMED CATHETER BREAK. CATHETER WAS STUCK: IT WAS BENT LIKE A CAPITAL LETTER "N". AFTER 4 HOURS, A VASCULAR SURGEON CUT 2" IN GOING TO TAKE IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC SOLO WITH TLS, MAXIMAL BARRIER PRECAUTION LJS C. R. BARD INC. (BASD) REUE0635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention