BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JP 1000ML EPUMP SET

    MDR report key: 11526381 · Received March 19, 2021

    Report

    Report Number
    1282497-2021-09981
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    March 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H2, H3, H4, H6 INVESTIGATION SUMMARY: THE CUSTOMER REPORTED LEAKAGE OCCURRED FROM NEAR THE VALVE. THERE WAS NO PATIENT HARM/INJURY REPORTED. THE REPORT REFERS TO PRODUCT CODE 973656, JAPANESE 1000ML FEED BAG EPUMP, WITH LOT NUMBER 201670039. THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE REPORTED LOT NUMBER SHOWS EVIDENCE THAT THE PRODUCT WAS RELEASED ACCORDING TO ALL ESTABLISHED PROCEDURES AND QA DOCUMENTATION. A TREND ANALYSIS WAS PERFORMED FOR THE REPORTED LOT NUMBER AND FAILURE MODE AND NO RELATED TRENDS WERE IDENTIFIED WITHIN A 2-YEAR TIMEFRAME. ONE (1) USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL EVALUATION PERFORMED COULD NOT CONFIRM THE REPORTED ISSUE OF LEAK. THE DEVICE MET SPECIFICATION REQUIREMENTS AND PERFORMED AS INTENDED. NO ACTION WILL BE TAKEN AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. INVESTIGATION.

    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 THE FEEDING SET WAS LEAKING FROM NEAR THE VALVE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426270 JP 1000ML EPUMP SET PUMP, INFUSION, ENTERAL LZH COVIDIEN 973656 201670039

    Patients

    Seq Age Sex Outcome Treatment
    1