BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDWELLING CATHETER

    MDR report key: 16933125 · Received May 15, 2023

    Report

    Report Number
    8040412-2023-00200
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    April 21, 2023
    Report Date
    April 21, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER (HANGZHOU CONOD MEDICAL CO LTD) FOR INVESTIGATION. CONOD MEDICAL REPORTS: "WE HAVE PROCEEDED WITH THE FOLLOWING INVESTIGATIONS AFTER RECEIVING THE COMPLAINT: 1. CHECK THE RECENT SITUATION OF PRODUCTION AND INSPECTION OF RELEVANT BELLY BAGS. THE PROCESSES ARE CLEAR, THERE IS NO CHANGE IN EQUIPMENT AND RAW MATERIALS. THE KEY PROCESSES HAVE BEEN EFFECTIVELY VERIFIED. THE PARAMETERS MEET THE REQUIREMENTS OF THE PROCESS CARD AND RELATED VERIFICATION DOCUMENTS. THERE IS NO ABNORMALITY DURING PRODUCTION. 2. ACCORDING TO THE COMPLAINT DESCRIPTION. THE CONNECTION BETWEEN THE END OF THE CATHETER AND THE URINE BAG FALLS OFF DURING USE, RESULTING IN LEAKAGE. AT PRESENT, THIS KIND OF PRODUCTS SOLD BY OUR COMPANY PROVIDE CUSTOMER WITH SELF-SELECTED CATHETERS FOR USE. THEREFORE, WE SPECULATE WHETHER SUCH INCIDENT IS RELATED TO THE FIT OF THE CATHETER USED BY THE CUSTOMER. OR THERE ARE SOME OTHER FACTORS RELATED TO THE USE PROCESS (SUCH AS FREQUENT PULLING FORCE WHILE WEARING). HOWEVER, AS THERE IS NO ACTUAL SAMPLE INFORMATION, WE CANNOT MAKE FURTHER CONFIRMATION. THE ROOT CAUSE CANNOT BE DETECTED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE REPORT STATES THAT "THE CONNECTION BETWEEN THE BELLY BAG AND THE CATHETER END IS NOT GOOD, THE BAG SLIPS OFF CAUSING LEAKAGE OF URINE. THE CATHETER [HAS BEEN IN PLACE FOR 4 WEEKS], SO NOT OLD". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    THE REPORT STATES THAT "THE CONNECTION BETWEEN THE BELLY BAG AND THE CATHETER END IS NOT GOOD, THE BAG SLIPS OFF CAUSING LEAKAGE OF URINE. THE CATHETER [HAS BEEN IN PLACE FOR 4 WEEKS], SO NOT OLD". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351305 INDWELLING CATHETER COLLECTOR, URINE, (AND ACCESSORIES) KNX TELEFLEX MEDICAL IPN053504

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown