BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3952728 · Received July 23, 2014

    Report

    Report Number
    1226348-2014-11838
    Event Type
    Injury
    Date Received
    July 23, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. COMPLAINT SAMPLE DISCARDED.

    Description of Event or Problem · 1

    MEDWATCH RECEIVED FROM THE CUSTOMER INFORMED THAT: "FLUID IN 3 DIFFERENT BURETROLS DID NOT DRAIN EASILY INTO COLLECTION BAGS WHEN STOPCOCK TURNED TO DRAIN POSITION. REQUIRED LOTS OF MANIPULATION TO GET BURETROLS TO DRAIN FLUID ALREADY COLLECTED IN IT TO THE COLLECTION BAG BELOW IT. HAPPENED IN PICU ON 3 PATIENTS - NOT IMMEDIATELY REPORTED TO RISK - EVD UNITS NOT SAVED FOR FURTHER EVALUATION. THE CURRENT LOT IN STOCK IS CRCB15 HOWEVER, THERE IS NO WAY TO KNOW WHAT THE NUMBERS WERE ON ANY OF THE 6 INSTANCES THAT OCCURRED DURING THE LAST 2 MONTHS AS NONE OF THE PACKAGING WAS RETAINED". PRODUCT WAS DISCARDED BY THE HOSPITAL. DATE OF EVENT IS BETWEEN (B)(6) 2014. ALSO SEE COMPLAINTS # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431111 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention