BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMODIALYSIS NON-IMPLANTED

    MDR report key: 2943965 · Received January 9, 2013

    Report

    Report Number
    3006260740-2013-00021
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 27, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    CATHETER FELL OUT DURING CLEANING/DRESSING CHANGE. NO DOCUMENTED INJURY TO PT AS RECEIVING DIALYSIS THROUGH AN ARTERIOVENOUS FISTULA. TREATMENT DISCONTINUED. RENAL CONSULTANT NOTIFIED AND MANUAL PRESSURE APPLIED TO SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13081 HEMODIALYSIS NON-IMPLANTED PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention