BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLS INTRG TBE ST UNTZ PLUG(CS)

    MDR report key: 3790783 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11551
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 4, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS NOT RETURNED IN THE ORIGINAL PACKAGE. EVALUATION OF THE PRODUCT CONFIRMED THE COMPLAINT. THERE IS A VERY SMALL PARTICLE ON THE INSIDE OF THE SPIKE/CONNECTION TUBE. THE EXACT CAUSE OF PARTICLE COULD NOT BE VERIFIED, HOWEVER; THE PARTICLE APPEARS TO BE IMBEDDED IN THE PLASTIC AND MOST LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. IT IS POSSIBLE THAT THIS PARTICLE WAS INTRODUCED DURING MANUFACTURING, HOWEVER; THIS COULD NOT BE CONFIRMED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT CODE, THEREFORE; THIS IS CONSIDERED TO BE AN ISOLATED INCIDENT. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE; IT IS NOT POSSIBLE TO EVALUATE THE DEVICE HISTORY RECORDS FOR THE SUBJECT PRODUCT. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    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

    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.

    Description of Event or Problem · 1

    FOREIGN MATTER WAS NOTED WHEN THE PACKAGE WAS OPENED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267193 MLS INTRG TBE ST UNTZ PLUG(CS) IRRIGATION TUBING SET; GENERAL PURPOSE GEI CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1