BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLY BAG

    MDR report key: 16872711 · Received May 4, 2023

    Report

    Report Number
    3011137372-2023-00120
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 14, 2023
    Report Date
    April 17, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    UDI-DI
    14026704661777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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 RECENT PRODUCTION AND INSPECTION OF THE PRODUCT IS CHECKED. THE PROCESSES OF THE PRODUCT ARE CLEAR, THERE IS NO CHANGE IN EQUIPMENT AND RAW MATERIALS. THE KEY PROCESSES INCLUDING WELDING HAVE BEEN EFFECTIVELY VERIFIED. THE WELDING MOLD OF THE INLET DOME HAS BEEN MAINTAINED EFFECTIVELY, AND THERE IS NO ABNORMALITY. THE PARAMETERS MEET THE REQUIREMENTS OF THE PROCESS CARD AND RELATED VERIFICATION DOCUMENTS. THE RETENTION SAMPLE WAS TESTED AND NO LEAKAGE OF THE INLET DOME WAS FOUND. AFTER THE ABOVE INVESTIGATIONS AND TESTS , WE DID NOT FIND ANY ABNORMALITY IN THE PRODUCT ITSELF. SINCE WE DID NOT RECEIVE THE ACTUAL SAMPLE, WE ANALYZED THE PRODUCT BASED ON THE ACTUAL USE PROCESS. THE POSITION OF THE DOME IS CONNECTED WITH THE CONNECTOR, AND THIS POSITION IS INDEED SUSCEPTIBLE TO SOME EXTERNAL FORCES IN THE ACTUAL USE (E.G. PULLING DURING THE ASSEMBLY OF THE CATHETER, SOME TURNING AND PULLING DURING THE CONTINUOUS WEAR OF IT OR SOME EXTERNAL FORCE, ETC.). THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO LACK OF ACTUAL SAMPLE." OTHER REMARKS: N/A CORRECTED DATA: N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE BAG LEAKED OUT AT THE 90-DEGREE INTAKE WHERE THE CATHETER CONNECTS". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE BAG LEAKED OUT AT THE 90-DEGREE INTAKE WHERE THE CATHETER CONNECTS". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858881 BELLY BAG COLLECTOR, URINE, (AND ACCESSO KNX TELEFLEX MEDICAL IPN039296 14026704661777

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown