BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18621780 · Received February 1, 2024

    Report

    Report Number
    3005778470-2024-00381
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Report Date
    January 25, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    30768455143543
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A2: AGE: 76, 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.

    Additional Manufacturer Narrative · 0

    ACCORDING TO G905704 VER.23.0 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 VER 1.0 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 SIMILAR COMPLAINTS RECEIVED ON THE LOT IN QUESTION WERE RECORDED IN TRACKWISE. -% AFFECTED PCS AGAINST THE LOT EQUALS 0,015%. THE DEFECT REPORTED IS BELOW THE AQL 0,4. THE INCREASED TREND OF COMPLAINTS, RELATED TO THE POUCH PAPER TEARS UNEVENLY DURING OPENING WAS OBSERVED. THEREFORE, CAPA 1832524 HAS BEEN RAISED TO ADDRESS THE ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4).

    Description of Event or Problem · 0

    END USER STATES "THE PAPER IS THINNER RIPPING UNEVENLY WHEN PEELING OPEN AND LEAKS THROUGH PAPER PACKAGING AFTER BURSTING WATER SACHET (THIS OCCURS AFTER 20-30 SECONDS AFTER BURSTING WATER SACHET)."

    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
    382890 GENTLECATH GLIDE CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 421568 3C03196 30768455143543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown