BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 7 FR. D/L CVC

    MDR report key: 1062791 · Received June 17, 2008

    Report

    Report Number
    3006260740-2008-00018
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 22, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED, BUT THE EXACT CAUSE IS UNKNOWN. A LEAK WAS DETECTED IN THE LUMEN WITH THE RED LUER ADAPTER. TWO HOLES WERE LOCATED 2.2 INCHES DISTAL TO THE CUFF. ONE OF THE HOLES WAS L-SHAPED. THE EXTERNAL SURFACE OF THE D/L TUBING EXHIBITED ABRASION AROUND THE LEAK SITES. IT IS POSSIBLE THAT THE TUBING WAS DAMAGED WITH MECHANICAL INSTRUMENTS, AND MAY HAVE OCCURRED DURING INSERTION; HOWEVER, THE EXACT CAUSE OF THE LEAK IS UNKNOWN. A CHR WAS NOT COMPLETED SINCE THE LOT INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE USER FELT PAIN AND DISCOMFORT AROUND THE SURE CUFF UPON FLUSHING HEPARIN FROM THE RED CATHETER. THE DEVICE HAD BEEN IN PLACE FOR 10 DAYS PRIOR TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 7 FR. D/L CVC LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention