BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN® MALIS® INTEGRATED TUBE SET UNITIZED PLUG

    MDR report key: 3933777 · Received July 15, 2014

    Report

    Report Number
    1226348-2014-11812
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GEI
    PMA / PMN Number
    PK890648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALIS TUBING SET WAS RETURNED UNOPENED AND IN THE ORIGINAL PACKAGING. PRODUCT CODE IS 80-1189 (MALIS TUBING SET). THE LOT CODE PROVIDED WAS 449672. SINCE THE LOT NUMBER WAS PROVIDED, THE PRODUCTION RECORD FOR THE RETURNED ITEM WAS REVIEWED. THE RECORD WAS COMPLETE AND NO NON-CONFORMANCES WERE FOUND. THE PRODUCT WAS RE-INSPECTED AND DID NOT PASS THE VISUAL AND TAPPI INSPECTION REQUIREMENTS. IN REVIEWING THE RETURNED ITEM, FOREIGN MATTER (LIKE A HAIR) WAS FOUND IN THE OUTER BARRIER FOR THE UNOPENED PACKAGE. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE MALIS TUBING SET WAS RETURNED UNOPENED AND IN THE ORIGINAL PACKAGING. SINCE THE LOT NUMBER WAS PROVIDED, THE PRODUCTION RECORD FOR THE RETURNED ITEM WAS REVIEWED. THE RECORD WAS COMPLETE AND NO NON-CONFORMANCES WERE FOUND. THE OPERATORS WERE RE-TRAINED. ANY ADDITIONAL COMPLAINTS FOR MALIS TUBING SETS WILL BE MONITORED. NO FURTHER ACTIONS ARE REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. DEVICE IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    FOREIGN MATTER (HAIR) WAS FOUND IN THE PACKAGE BEFORE USE. USER TRAINING SCHEDULE IS UNKNOWN. THERE WAS NO SURGICAL DELAY. THIS IS NOT THE PATIENT RELATED MATTER WHICH OCCURRED BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412082 CODMAN® MALIS® INTEGRATED TUBE SET UNITIZED PLUG IRRIGATION TUBING SET, GENERAL PURPOSE GEI CODMAN & SHURTLEFF 449672

    Patients

    Seq Age Sex Outcome Treatment
    1