BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3012368 · Received March 20, 2013

    Report

    Report Number
    1226348-2013-14101
    Event Type
    Injury
    Date Received
    March 20, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE TUBING WAS FOUND TO BE DISCONNECTED FROM THE 3 WAY STOP COCK. GLUE TRACES WERE FOUND ON THE TUBING AND THE 3 WAY STOP COCK, AS WELL BIOLOGICAL DEBRIS LOCATED IN THE 3 WAY STOP COCK. ALL OF THE OTHER CONNECTIONS WERE FINE. IT IS NOT POSSIBLE TO DETERMINE HOW THE TUBING BECAME DISCONNECTED. THE DEVICE WAS LEAK TESTED TO SEE IF ANY OTHER DEFECTS COULD BE FOUND, APART FROM DEFECTS ALREADY NOTED AND NO OTHER DEFECTS WERE NOTED. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TESTED FOR LEAKS AND BLOCKAGES. A REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE IN THE ALERT DATE TO 2/11/2013.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EDS3 CAME APART AT THE STOPCOCK CLOSEST TO THE PATIENT. NO OTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE CUSTOMER REPORTED THAT: "EDS3 CAME APART AT THE STOPCOCK CLOSEST TO THE PATIENT". ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP. ON (B)(6), 2013: "I JUST SPOKE WITH CHARGE NURSE WHO SAID "THE NURSE WAS PROVIDING CARE AND NOTICED SOME FLUID ON THE BED WHERE DRAIN HAD DISCONNECTED. THEY REPLACED THE DRAIN AND THERE WAS NO EFFECT ON THE PT.". A FOLLOW-UP IS BEING GENERATED DUE TO A CHANGE IN THE ALERT DATE TO 2/11/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116775 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH UNKNOWN DEVICE JXG CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention