BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 3922093 · Received July 9, 2014

    Report

    Report Number
    1226348-2014-11802
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 2, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION. UPON RECEIPT OF THE DEVICE THE COMPLAINT WILL BE RE-OPENED AND AN EVALUATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EDS III WAS VISUALLY INSPECTED AND CONFIRMED THAT THE TUBING HAS COME AWAY FROM THE PATIENT LINE STOP COCK, GLUE TRACES WERE NOTED ON THE TUBING AND THE STOP COCK. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TEST FOR LEAK AND BLOCKAGE. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE EDS III WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOW. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE BACTISEAL CATHETER WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOW. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. NO PROBLEM WAS NOTED WITH THE BACTISEAL CATHETER. TRENDS WERE MONITORED FOR THIS KIND OF PROBLEM AND A CAPA -0001626 WAS OPENED. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    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. DEVICE COMPLAINT SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM CUSTOMER ON 7/11/14: I CONTACTED THE SALES REP AGAIN, AND SHE INFORMED ME THAT THE DISTRIBUTOR WILL BE SENDING THE COMPLAINT PRODUCT NEXT WEEK, SO THAT WE CAN SEND TO THE MANUFACTURER FOR ANALYSIS REGARDING THE PATIENT, THE PATIENT IS AN INTENSE CARE PATIENT. COMPLAINT PRODUCT 821730 HAS BEEN USED WITH PRODUCT 821745. THE DIRECT CONTACT WITH THE PATIENT IS ONLY 821745. AFTER WE HAVE BEEN INFORMED ABOUT THE COMPLAINT, THE COMPLAINT PRODUCT HAS BEEN IMMEDIATELY CHANGED WITH A NEW ONE. INTENSE CARE OF THE PATIENT IS ONGOING. THERE IS NO COMPLAINT ABOUT THE PRODUCT. PLEASE NOTE: AT THE TIME OF THE INTIAL REPORT THE BACTISEAL WAS NOT REPORTED. HOWEVER THE PRIMARY SOURCE OF THE COMPLAINT WAS DUE TO LEAKAGE AT THE 3 WAY STOP COCK.

    Description of Event or Problem · 1

    THERE WAS LEAK ON THE TRIPLE TAP OF EVD WHICH WAS IMPLANTED.THAT'S WHY BOS DRAINAGE CANNOT BE MEASURED ACCURATELY. (DURING USE ON PATIENT) PLEASE NOTE THAT THE SYNERGY REPORTS THAT THE SAMPLE WAS DISCARDED. THERE IS NO LOT/ SERIAL NUMBER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401697 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention