BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRGRSHNG CATH 5F BASICTRAY SL 45CM

    MDR report key: 3853867 · Received April 16, 2014

    Report

    Report Number
    3006260740-2014-00183
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 24, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K063848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REWF0213 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (REWF0213) HAVE BEEN REPORTED FROM ONE (B)(6) FACILITY.

    Description of Event or Problem · 1

    THEY REPORTED DURING THE PROCEDURE, THEY NOTED A LIQUID FLOWS OUT FROM THE INSERTION SITE. REMOVING THE DEVICE THEY NOTE A BROKEN RUPTURE A 2CM NEAR THE INTERNAL POINT OF INSERTION. NO DAMAGES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233848 PWRGRSHNG CATH 5F BASICTRAY SL 45CM LJS C.R. BARD, INC. (BASD) REWF0213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention