BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18580975 · Received January 25, 2024

    Report

    Report Number
    3005778470-2024-00285
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    January 24, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    UDI-DI
    30768455143550
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 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. SIMILAR COMPLAINTS RECEIVED ON THE LOT IN QUESTION WERE RECORDED IN TRACKWISE. NO SAMPLES PROVIDED. -% AFFECTED PCS AGAINST THE LOT EQUALS (B)(4). 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: 1049092. MANUFACTURING SITE: 3005778470.

    Additional Manufacturer Narrative · 0

    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

    DISTRIBUTOR REPORTS "PAPER ON PACKAGING TEARING UNEVENLY WHEN OPENING. HE COULD NOT QUANTITY HOW MANY AS HE SAID HE OPENED A FEW FROM MULTIPLE BOXES OF ALL OF THE LOTS REPORTED." THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS WITH THE PACKAGING DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898453 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421569 3B02711 30768455143550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown