BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F X 32CM SPLIT CATH III

    MDR report key: 3063245 · Received April 11, 2013

    Report

    Report Number
    2518902-2013-00019
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 7, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDCOMP
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REC'D ONE INTACT 14F X 32CM SPLIT CATH III. A VISUAL EXAMINATION OF THE DEVICE REVEALED NO VISIBLE DAMAGE TO THE CATHETER. THE CUFF IS INTACT IN THE CORRECT LOCATION. THERE IS EVIDENCE OF BLOOD ON THE CUFF. A REVIEW OF THE MFG RECORDS INDICATED ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS EVENT. EACH PT HAS A DIFFERENT REACTION TO AN IMPLANTED FOREIGN BODY AND TISSUE IN-GROWTH IS RELATED TO THIS REACTION. MANY VARIABLES CONTRIBUTE TO THE ENCAPSULATION OF A TEXTILE. THESE INCLUDE FACTORS RELATED TO SURGICAL TECHNIQUE, PT HEMATOLOGY, AND CONCURRENT DRUG THERAPY. POTENTIAL CAUSES FOR INADEQUATE TISSUE IN-GROWTH INCLUDE: INFECTION, METHOD FOR CATHETER FIXATION, WETTING THE CATHETER PRIOR TO INSERTION (WETTING MAY IMPEDE TISSUE IN-GROWTH INTO THE CUFF), USE OF DRUGS OR OTHER AGENTS THAT MAY IMPEDE TISSUE IN-GROWTH, POSITION OF THE CUFF IN RELATION TO THE EXIT SITE, SITE CARE, DIAMETER OF TUNNEL FOR INSERTION, CUFF SIZE, AND CUFF SIZE, AND CUFF NAP (WEAVE OR FLUFFINESS).

    Description of Event or Problem · 1

    CATHETER FELL OUT AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155286 14F X 32CM SPLIT CATH III HEMODIALYSIS CATHETER MSD MEDCOMP ASPC32-3E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention