BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18614340 · Received January 31, 2024

    Report

    Report Number
    3005778470-2024-00380
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Report Date
    January 29, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO G905704 VER 24.0 WITHIN IN-PROCESS THE PEELTEST IS CARRIED OUT. POINT 5.11.3 PEELPACK MUST NOT BE SEALED SO STRONG THAT PAPER RESIDUES REMAINED ON THE FOIL OR PAPER TEARS. SEAL SHOULD BE ENOUGH STRONG TO KEEP PAPER AND FOIL TOGETHER WITHOUT ANY IRREGULARITIES. REVIEW OF TEST RESULTS, RECORDED IN FORM G906996 V1.0, WAS CARRIED OUT AND ALL SAMPLES PASSED PEELTEST REQUIREMENTS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION AND STERILIZATION PROCESS OF THE MENTIONED LOT. NO OTHER SIMILAR COMPLAINT RELATED TO ISSUE WITH PAPER TEARS WAS RECEIVED ON THE LOT 3B03079. COMPLAINT WAS SUBMITTED TO COMPLAINT REVIEW BOARD HELD ON (B)(6) 2024. % AFFECTED PCS AGAINST THE LOT EQUALS 0,002. PERCENTAGE OF AFFECTED PCS REPORTED IS ABOVE AQL0,4. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS A NEW CAPA#1832524 WAS OPENED. CAPA OPENED 20/FEB/2024 AND IT IS IN INVESTIGATION STATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    A2: SEX: MALE 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    END USER REPORTS PAPER TEARING UNEVENLY WHEN OPENING. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245799 GENTLECATH GLIDE CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 421909 3B03079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown