BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3823909 · Received May 21, 2014

    Report

    Report Number
    1226348-2014-11621
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    August 29, 2013
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. (B)(4).

    Description of Event or Problem · 1

    REP REPORTED THAT THE TUBING BROKE. IT IS NOT CLEAR AT THIS POINT WHERE AS THE DEVICE IS ALREADY PACKAGED UP. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND ONLY THE SYSTEM WAS CHANGED. THE CATHETER WAS LEFT IN PLACE. IT WAS ASKED IF THERE WAS CSF LEAKAGE AT ANY POINT. MORE INFORMATION IS EXPECTED. (B)(4) REP CONFIRMED THAT THERE WAS NO LEAKAGE. (B)(4) REP CONFIRMED THAT THE HOSPITAL HAS DISCARDED THE DRAIN. EXPLANT KITS WERE SENT TO THE CUSTOMER ON (B)(4). (B)(4) DRAINS WERE DISCARDED. (B)(4). AN INITIAL MEDWATCH IS BEING GENERATED TO FILE THIS COMPLAINT AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303182 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention