BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD

    MDR report key: 3243157 · Received July 18, 2013

    Report

    Report Number
    3006260740-2013-00352
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 28, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DETACHED SURECUFF AND HEAT SLEEVE IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS CONFIRM A COMPLETE SEPARATION OF THE SURECUFF/ HEAT SLEEVE FROM THE CATHETER. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. A LOT HISTORY REVIEW (LHR) OF REWH1477 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) 2013, THE DOCTOR PLANED TO PLACE A LONG TERM DIALYSIS CATHETER FROM RIGHT IJ VEIN. HE USED THE SUTURE TO SECURE THE CATHETER. POVIDONE-IODINE CLEAN THE CATHETER. DATE (B)(6) 2013, THE CATHETER WAS OUT OF POSITION DURING HEMODIALYSIS. THE DOCTOR CHECKED AND FOUND THAT THE CUFF WAS DETACHED FROM THE CATHETER. THE CUFF STILL IN PATIENT'S BODY, TISSUE IN-GROWTH THE CUFF. THE CATHETER WAS OUT OF THE BODY. THE DOCTOR HAS TO CHANGE TO DIALYSIS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336427 HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD MSD C. R. BARD INC. (BASD) REWH1477

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention