BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS INTERGRATED TUBE SET UNITIZED PLUG

    MDR report key: 3790055 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11535
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    May 9, 2012
    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

    IT WAS NOTED UPON REVIEW OF THE PRODUCT CODE 80-1189 THAT THE INCORRECT BASELINE INFORMATION WAS REPORTED ON THE INITIAL MEDWATCH. A FOLLOW-UP IS BEING SUBMITTED TO CORRECT THE INFORMATION FOR THIS PRODUCT CODE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THIS INVESTIGATION IT WAS NOTED THAT THE FOREIGN MATTER IS BELIEVED TO BE SOME TYPE OF CARDBOARD MATERIAL. THE PACKAGING PROCESS WAS REVIEWED. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. ONE POTENTIAL ROOT CAUSE IS THE FOREIGN MATTER MAY HAVE COME FROM THE VENDOR PURCHASED COMPONENT, HIDDEN WITHIN A FOLD. ANOTHER POTENTIAL ROOT CAUSE IS THE FOREIGN MATTER MAY HAVE COME FROM THE (B)(4) ROLL USED TO SEAL THE OUTER PACKAGE. THE PACKAGING OPERATORS WERE MADE AWARE OF THE COMPLAINT. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION WAS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    FOREIGN MATTER WAS NOTED IN THE PACKAGE BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DELAY IN SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268684 MALIS INTERGRATED TUBE SET UNITIZED PLUG IRRIGATION TUBING SET; GENERAL PURPOSE GEI CODMAN & SHURTLEFF 189914

    Patients

    Seq Age Sex Outcome Treatment
    1