BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD

    MDR report key: 2901265 · Received January 8, 2013

    Report

    Report Number
    1226348-2013-10570
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE VALVE WAS VISUALLY INSPECTED AND CONFIRMED THAT THE BASE OF THE NEEDLE CHAMBER WAS MISSING. THE BASE OF THE NEEDLE CHAMBER WAS NOT RETURNED FOR INVESTIGATION. IT WAS NOT POSSIBLE TO DETERMINE THE REASON WHY THE BASE OF THE NEEDLE CHAMBER CAME AWAY. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED AS THE BASE OF THE NEEDLE CHAMBER WAS NOT RETURNED WITH THE VALVE. IF THE BASE DOES BECOME AVAILABLE THE COMPLAINT WILL BE REOPENED AND INVESTIGATED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    WHEN REMOVED THE VALVE FORM PATIENT, THE BACK PLASTIC OF RESERVOIR BAG WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9350 PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CLKCTT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention