BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP 1000ML EPUMP SET

    MDR report key: 12144746 · Received July 9, 2021

    Report

    Report Number
    1282497-2021-10484
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    July 8, 2021
    Report Date
    December 30, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION THE CUSTOMER REPORTED, WH:ILE IN USE IN A CLINICAL ENVIRONMENT, A LEAK WAS OBSERVED AT THE CONNECTION OF THE FEEDING BAG AND THE TUBE. THE REPORT REFERS TO PRODUCT CODE 973656, JAPANESE 1000ML FEED BAG EPUMP, WITH LOT NUMBER UNK. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT BE PERFORMED AS THE LOT NUMBER REPORTED WAS UNKNOWN. ONE USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED CONFIRMED THE REPORTED FAILURE AS A LEAK WAS IDENTIFIED AT THE BOTTOM OF THE BAG. AN INVESTIGATION WAS INITIATIATED TO DETERMINE THE ROOT CAUSE OF THE CONFIRMED PRODUCT FAILURE. THE ROOT CAUSE WAS IDENTIFIED A MACHINERY ISSUE. A CORRECTIVE ACTION TO REPLACE THE RF SEALING MACHINE WAS IMPLEMENTED. ADDITIONAL ACTION WILL NOT BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR MONITORING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, WHILE IN USE IN A CLINICAL ENVIRONMENT, A LEAK WAS OBSERVED AT THE CONNECTION OF THE FEEDING BAG AND THE TUBE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041319 JP 1000ML EPUMP SET PUMP, INFUSION, ENTERAL LZH COVIDIEN 973656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown