BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 19497434 · Received June 10, 2024

    Report

    Report Number
    3005778470-2024-00883
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Report Date
    June 3, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    30768455143536
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1:COMPLAINANT STREET ADDRESS: CONVACARE CLINICS. COMPLAINANT CITY: BOGOTÁ. COMPLAINANT STATE/PROVINCE: CUNDINAMARCA. 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: 1049092. MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1718756 - GENTLECATH GLIDE MALE CH12 (1X30PK) EUR AND MANUFACTURING LOT#2L03638 IN C2 ON PACKAGING MACHINE P020 IN AMOUNT 270000 PIECES IN DECEMBER 2022. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION OR STERILIZATION PROCESS OF THE MENTIONED LOT. NO ANOTHER COMPLAINT HAS BEEN RECEIVED ON THIS LOT AND NATURE. DURING LOT PRODUCTION WAS USED PAPER PAPER GAS COAT NRW GRID GLIDE MALE XRAY, SUPPLIER LOT#OF/31216 AND LOT# OF/31586, SAP 1736865. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS WAS OPENED NEW CAPA#1832524 - INCREASED COMPLAINT TREND RELATED TO THE ISSUE PEELPACK PAPER TEARING UNEVENLY WHEN OPENING GENTLECATH GLIDE. CAPA OPENED 20/FEB/2024 AND IT IS IN IMPLEMENTATION PHASE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE ADHESIVE TAPE IS DIFFICULT TO REMOVE AND SHOULD HAVE A FREE EDGE FOR EASY REMOVAL ESPECIALLY FOR DISABLED PATIENTS. WHEN OPENING THE PRIMARY PACKAGING OF THE PROBE, THE OPENING HANDLES BREAK OR TEAR EASILY.".

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666159 GENTLECATH GLIDE CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 421566 2L03638 30768455143536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male