BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR S/L POWERPICC - NURSING BASIC

    MDR report key: 3061609 · Received April 11, 2013

    Report

    Report Number
    3006260740-2013-00150
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 15, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED "INSERTED (B)(6) 2013. NOTED TO HAVE HOLE DISTAL TO WINGS. REMOVED AND REPLACED." LEAK WAS FOUND TO BE AT THE 13CM MARK DURING DECONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157230 4 FR S/L POWERPICC - NURSING BASIC LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention