BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP 1000ML EPUMP SET

    MDR report key: 11728489 · Received April 26, 2021

    Report

    Report Number
    1282497-2021-10114
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 23, 2021
    Report Date
    November 1, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED THAT THE DEVICE PRESENTED A LEAK THROUGH THE FLUSHING BAG BEFORE USE. PATIENT WAS NOT INVOLVED. THE REPORT REFERS TO PRODUCT CODE 973656, APANESE 1000ML FEED BAG EPUMP WITH AN UNKNOWN LOT NUMBER AS THE CUSTOMER REPORTED TWO POTENTIAL LOT NUMBERS (203280094 AND 202580009). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR BOTH POTENTIAL LOT NUMBERS AND SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QA DOCUMENTATION. LOT AND FAILURE MODE TRENDING WAS REVIEWED AND NO RELATED ADVERSE TRENDS WERE IDENTIFIED. ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING PERFORMED CONFIRMED THE REPORT OF LEAK BETWEEN THE BOTTOM OF THE BAG AND THE BUSHING TUBE. AN INVESTIGATION WAS INITIATED AND DETERMINED THE ROOT CAUSE IS RELATED TO THE RF SEALING MACHINE PROCESS. A CORRECTIVE ACTION WAS COMPLETED TO REPLACE THE RF SEALING MACHINE. ADDITIONAL ACTION WILL NOT BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    FACILITY NAME SHOULD REFLECT "(B)(6). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER SWITCHING TO THE EPUMP SETS WITH THE EN-FIT CONNECTOR, THERE WAS A LEAK FROM THE JOINT POINT BETWEEN THE BAG AND THE TUBE PARTS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621085 JP 1000ML EPUMP SET PUMP, INFUSION, ENTERAL LZH COVIDIEN 973656

    Patients

    Seq Age Sex Outcome Treatment
    1