BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLY BAG

    MDR report key: 16763697 · Received April 18, 2023

    Report

    Report Number
    3011137372-2023-00101
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 28, 2023
    Report Date
    March 28, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    UDI-DI
    14026704661777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(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 HISTORICAL COMPLAINTS WITHIN 12 MONTHS WERE REVIEWED AND THERE ARE SIMILAR ISSUES BEFORE. HOWEVER, WE HAVE NOT FOUND ANY DEVIATION IN THE PRODUCTION AND INSPECTION PROCESSES THROUGH INVESTIGATION. 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 HAVE BEEN FOUND. THE RELATED 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. ALSO IT CAN BE CLOSED TIGHTLY WITHOUT LEAK." WE DID NOT FIND ANY DEVIATION IN THE PRODUCTION AND INSPECTION PROCESSES OF THIS PRODUCT. SO WE THINK THAT THEIR 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 IS 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

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT THAT THE "BELLY BAGS SHE PURCHASED ONLINE RECENTLY APPEAR TO HAVE CHANGED FROM WHAT SHE HAS RECEIVED IN THE 10+ YEARS OF USE. SHE NOTES THAT THE DRAIN VALVE IS MUCH MORE DIFFICULT TO TWIST AND THAT THE DRAIN TUBE ALSO SEEMS TO BE A LITTLE LONGER". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    THE CUSTOMER CALLED TO REPORT THAT THE "BELLY BAGS SHE PURCHASED ONLINE RECENTLY APPEAR TO HAVE CHANGED FROM WHAT SHE HAS RECEIVED IN THE 10+ YEARS OF USE. SHE NOTES THAT THE DRAIN VALVE IS MUCH MORE DIFFICULT TO TWIST AND THAT THE DRAIN TUBE ALSO SEEMS TO BE A LITTLE LONGER". NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188038 BELLY BAG COLLECTOR, URINE, (AND ACCESSO KNX TELEFLEX MEDICAL IPN039296 14026704661777

    Patients

    Seq Age Sex Outcome Treatment
    1 Female