BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J001FO 1000ML JOEY FEED BAG TYPE X30

    MDR report key: 10294821 · Received July 20, 2020

    Report

    Report Number
    8040459-2020-00535
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 20, 2020
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. THE CUSTOMER REPORTED A NON-REPORTABLE PRODUCT MALFUNCTION AND RETURNED THE SAMPLE FOR EVALUATION. THE SAMPLE ARRIVED AT THE MANUFACTURING SITE WITHOUT THE PACKAGING OR LOT NUMBER. THE SAMPLE WAS EVALUATED ON JULY 15, 2020 BY VISUAL INSPECTION AND PUMPING TESTER. UPON EVALUATION A LEAKAGE OCCURRED FROM THE AFF VALVE WHICH IS EXTERNALLY SUPPLIED. CARDINAL HEALTH HAS REQUESTED THAT THE SUPPLIER IMPLEMENT CORRECTIVE ACTIONS TO PREVENT THE REOCCURRENCE OF THE ISSUE. THE MANUFACTURING SITE HAS ALSO CONDUCTED CONTAINMENT ACTION BY 100% AFF VALVE LEAK TEST AT THE OCCLUSION/LEAK TEST MACHINE UNDER CONDITION 1 BAR, 20 SECONDS BEFORE SENDING THE PUMPING SECTION TO THE ASSEMBLY LINE. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A NON-REPORTABLE PRODUCT MALFUNCTION AND RETURNED THE SAMPLE FOR EVALUATION. UPON EVALUATION ON JULY 15, 2020 A LEAKAGE OCCURRED FROM THE AFF VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760997 J001FO 1000ML JOEY FEED BAG TYPE X30 PUMP, INFUSION, ENTERAL LZH COVIDIEN J001FO

    Patients

    Seq Age Sex Outcome Treatment
    1