BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18985851 · Received March 27, 2024

    Report

    Report Number
    3005778470-2024-00815
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Report Date
    April 19, 2024
    Manufacturer
    CONVATEC
    Product Code
    GBM
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    URINARY CATHETER IN QUESTION WAS MANUFACTURED ON PACKAGING MACHINE P009 IN AMOUNT (B)(4)PCS. 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 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. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS OPENED CAPA#1832524 WAS INITIATED. 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

    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 WHEN TRYING TO PEEL OPEN PACKAGING. HE SAID THE PAPER ITSELF FEELS MORE "DRY" AND IT SEEMS THE TOP TAB IS TICKING TOO WELL TO HOLD IT TOGETHER AND IT JUST TEARS OFF AND PAPER TEARS UNEVENLY. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493347 GENTLECATH GLIDE CATHETER, URETHRAL GBM CONVATEC 421910 3C01306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown