BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER 6F STANDARD

    MDR report key: 3240947 · Received July 17, 2013

    Report

    Report Number
    3006260740-2013-00346
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWG0956 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT AS REPORTED FROM THE CUSTOMER: CATHETER INSERTED (B)(6) 2013, DURING HEMODIALYSIS, MACHINE ALARMING, STAFF ATTENDED PT AND OBSERVED LINE LOOKED LONGER. DIALYSIS STOPPED, ON REVIEW THE CATHETER HAD CLEARLY MOVED, CUFF ALMOST EXPOSED. PT HAD RIJV CATHETER. REVIEWED BY RENAL REGISTRAR, DECISION MADE TO REMOVE CATHETER. PT HAD NEW TUNNELLED CATHETER INSERTED ON OPPOSITE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332114 HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER 6F STANDARD MSD C. R. BARD INC. (BASD) REWG0956

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention