BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM BACTISEAL

    MDR report key: 2123435 · Received June 10, 2011

    Report

    Report Number
    2123435
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HCA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A TODDLER. SHUNT WAS PLACED APPROXIMATELY 2.5 YEARS AGO FOR HYDROCEPHALUS. PATIENT WAS NOTED TO HAVE POOLING OF SUBCUTANEOUS FLUID AROUND THE SHUNT COMPONENTS. A SHUNT SURVEY WAS DONE AND SHOWED A DISCONNECTION JUST AT THE BOTTOM SIDE OF HER VALVE. CSF WAS FOUND TO BE FREELY COMING FROM THE DISTAL VALVE. THE ORIGINAL CONNECTION OF THE DISTAL CATHETER TO THE VALVE WAS STILL INTACT WITH THE SUTURE IN PLACE, BUT THE CATHETER HAD RUPTURED JUST 0.5 CM BELOW THIS. A NEW BACTISEAL PERITONEAL TUBING WAS PULLED INTO PLACE. THE OLD PERITONEAL CATHETER WAS THEN REMOVED AND WAS SENT FOR PATHOLOGIC EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM BACTISEAL CATHETER, VENTRICULAR HCA CODMAN & SHURTLEFF, INC. 82-3072 CJCBK6

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| R