BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH OTHER

    MDR report key: 20937762 · Received December 16, 2024

    Report

    Report Number
    3005778470-2024-01112
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Report Date
    December 11, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K172924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE PROCESS INSTRUCTIONS G805307 VER.28.0 PRODUCTION OF GENTLECATH CATHETERS, THE POSITION OF CONNECTOR INDICATOR AGAINST BENT TIP OF CATHETER IS CHECKED BY TECHNICIAN DURING ORDER SET UP ¿ 2 PCS FROM EACH MOLDING STATION AND VISUAL INSPECTION WITH FOCUS ON TIEMANN INDICATOR POSITION WAS CARRIED OUT BY OPERATORS AT THE BEGINNING OF EACH SHIFT ACCORDING TO TM-422 V.2.0. THE POSITION OF CONNECTOR INDICATOR AGAINST TIEMANN TIP OF CONNECTOR IS PERMANENTLY CHECKED DURING THE WHOLE MANUFACTURING PROCESS AND WRITTEN DOWN IN THE FORM G905800, FORM 3. MACHINE A097 IS EQUIPPED BY VISION SYSTEM. THE KEY POINT FOR INSTALLATION AND SETTING VISION SYSTEM IS TO PROVIDE A CONTROL OF ALL CATHETERS WITH THE FOCUS ON CATHETERS FAILURE: - EYELET NO PUNCH, - HANGNAIL LEFT IN EYELETS AND - POSITION OF CONNECTOR INDICATOR AND BENT TIP OF CATHETER. VISION SYSTEM MUST REJECT EVERY CATHETER WITH AT LEAST OF ONE FAILURE MENTIONED ABOVE. VALIDATION OF THE POSITION OF TIEMANN INDICATOR WAS IN SCOPE OF CCR-01239. CCR-01239 WAS SIGNED ON DECEMBER 19TH, 2019. LOT IN QUESTION WAS PRODUCED AFTER VALIDATION OF THE CAMERA. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOT. NO ANOTHER COMPLAINT WAS RECEIVED TO THIS LOT. THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    E.1: COMPLAINANT STREET ADDRESS: (B)(6). COMPLAINANT CITY: (B)(6). COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT POSTAL CODE: (B)(6). PATIENT COUNTRY: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED "THERE ARE A FEW CATHETERS THAT HAVE THE INDICATOR LINE NOT ALIGNED WITH THE COUDÉ TIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311815 GENTLECATH OTHER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 501014 3H04672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown