BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL

    MDR report key: 3052141 · Received April 11, 2013

    Report

    Report Number
    1226348-2013-15176
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK003322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. PLEASE NOTE THAT A THERAPY DATE IS A REQUIRED FIELD AND THAT FIELD IS NOT APPLICABLE TO THIS PRODUCT. THEREFORE A DATE THE MEDWATCH WAS INITIATED WAS USED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE STERILIZATION RECORDS WERE REVIEWED AND THEY CONFIRMED THAT THE DEVICE CONFORMED TO ALL REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. THE ROOT CAUSE FOR THE INFECTION REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. DURING THE INVESTIGATION IT WAS HOWEVER NOTED THAT THE DEVICE FAILED PROGRAMMING AND PRESSURE TEST. BIOLOGICAL DEBRIS APPEARS TO HAVE BEEN THE ROOT CAUSE FOR THE PROGRAMMING AND PRESSURE CONTROL ISSUES. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE ANTIBACTERIAL PROGRAMMABLE SHUNT BECAME INFECTED. AS A RESULT, THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154767 HAKIM VENTRICULAR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL, NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNNC48

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 82-3184