BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLY BAG

    MDR report key: 16682101 · Received April 5, 2023

    Report

    Report Number
    3011137372-2023-00097
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 22, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    UDI-DI
    14026704661777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE MANUFACTURER (HANGZHOU CONOD MEDICAL CO LTD) REPORTS "THE DHR RECORD OF IT IS CHECKED. THE INCOMING, IN-PROCESS AND FINAL INSPECTION ARE COMPLETED. ALL RESULTS MEET THE STANDARD. CHECK THE PRODUCTION AND INSPECTION PROCESS OF THE PRODUCT IN RECENT MONTHS, THEY ARE IN LINE WITH THE STANDARD. THE RAW MATERIALS AND PRODUCTION PROCESS OF THIS PRODUCT HAVE NO CHANGE, AND NO ABNORMALITY WAS REPORTED. THE RELEVANT IN-COMING INSPECTION RECORDS OF THE DRAIN VALVE ARE NORMAL. THE DRAIN VALVES IN THE INVENTORY ARE RANDOMLY SELECTED FOR INSPECTION. THEY CAN BE OPENED, CLOSED NORMALLY AND USED SMOOTHLY. AFTER THE ABOVE INVESTIGATIONS, WE DID NOT FIND ANY DEVIATION IN THE PRODUCTION AND INSPECTION PROCESSES OF THIS PRODUCT. WE THINK THAT THE CUSTOMER'S FEEDBACK MAY BE RELATED TO THEIR OWN USE. IN ADDITION, DUE TO THE STRUCTURAL CHARACTERISTICS OF THE PRODUCT ITSELF, MOST CUSTOMERS WILL MAINTAIN A NORMAL STATE OF LIFE AND MOVEMENT WHEN USING. IF THE VALVE IS OPENED AND CLOSED TOO EASILY, IT VERY EASY TO CAUSE LEAK. BASED ON THE INVESTIGATION AND ANALYSIS, WE SUGGEST THAT CUSTOMERS SHOULD USE BOTH HANDS TOGETHER WHEN OPENING AND CLOSING THE VALVE." OTHER REMARKS: N/A, CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DRAIN VALVE IS NOT WORKING PROPERLY. SEE ASSOCIATE MDRS 3011137372-2023-00098, 3011137372-2023-00099

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DRAIN VALVE IS NOT WORKING PROPERLY. SEE ASSOCIATE MDRS 3011137372-2023-00098, 3011137372-2023-00099.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242328 BELLY BAG COLLECTOR, URINE, (AND ACCESSO KNX TELEFLEX MEDICAL IPN039296 20220601 14026704661777

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown