BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3030533 · Received April 2, 2013

    Report

    Report Number
    1226348-2013-14732
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE EDS III WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE TUBING FROM THE NEEDLESS PORT (PATIENT LINE) WAS NOT RETURNED; HOWEVER GLUE TRACES WERE FOUND ON THE NEEDLESS PORT. IT IS POSSIBLE THAT WHEN RELEASING THE SLIDING CLAMP THIS HAS PULLED ON THE TUBING DISCONNECTING IT, BUT THIS COULD NOT BE DETERMINED. NO OTHER LEAKS WERE FOUND. 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 SINCE 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

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

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE HOSPITAL HAD AN EVD SYSTEM COME APART. THE NURSE CLAMPED THE EVD FOR THE PATIENT TO USE THE BATHROOM. WHEN THE PATIENT RETURNED, THE NURSE UNCLAMPED THE TUBING AND THE TUBING CAME APART FROM THE ATTACHED PORT. THE SYSTEM WAS REVISED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135030 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention