BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 18580872 · Received January 25, 2024

    Report

    Report Number
    3005778470-2024-00283
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    January 22, 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

    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. 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 G906996V1.0, WAS CARRIED OUT AND ALL SAMPLES PASSED PEELTEST REQUIREMENTS. ONE SIMILAR COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION WITH PICTURES OF BOXES, WHERE THE DEFECTIVE CATHETERS WERE FOUND WAS PROVIDED. COMPLAINT WAS SUBMITTED TO COMPLAINT REVIEW BOARD HELD ON FEBRUARY 16TH, 2024. -% AFFECTED PCS AGAINST THE LOT EQUALS 0,75. PERCENTAGE OF AFFECTED PCS REPORTED WITHIN BOTH COMPLAINTS IS ABOVE AQL0, 4. 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 THE "PAPER ON PACKAGING TEARING UNEVENLY WHEN OPENING. HE CHECKED MULTIPLE CATHETERS FROM MULTIPLE MUS HE HAD IN HIS SUPPLY STORE OF 421569 AND NOTED EVERY SINGLE ONE HE TRIED TO OPEN HAD THE SAME ISSUE. HE NOTICED AS HE OPENED THEM BY PEELING THE TABS APART, THE PAPER WAS RIPPING ANYWHERE FROM 1/4 OF THE WAY TO 1/2 DOWN." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT. THIS EMDR COVERS THE UNKNOWN NUMBER OF CATHETERS FROM MULTIPLE MARKET UNITS WITH DEFECTIVE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173385 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421569 3C04454 30768455143550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown