BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 19104991 · Received April 15, 2024

    Report

    Report Number
    3005778470-2024-00822
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Report Date
    April 8, 2024
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED ON PACKAGING MACHINE P009 IN AMOUNT 198,000PCS. 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 G906128 VER. 2.0, WAS CARRIED OUT AND ALL SAMPLES PASSED PEELTEST REQUIREMENTS. RELEVANT IN-PROCESS TEST RELATED TO THE ISSUE WAS TM-410 VER.3.0 PEEL TEST OF PEEL PACKS. 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. DURING LOT PRODUCTION WAS USED PAPER PAPER GAS COAT NRW GRID GLIDE MALE XRAY, SUPPLIER LOT#OF/31358, SAP 1736865. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS WAS OPENED NEW CAPA#1832524 - INCREASED COMPLAINT TREND RELATED TO THE ISSUE PEELPACK PAPER TEARING UNEVENLY WHEN OPENING GENTLECATH GLIDE. CAPA OPENED 20/FEB/2024 AND IT IS IN INVESTIGATION STATE. COMPLAINT WAS SUBMITTED TO COMPLAINT REVIEW BOARD ON 18ST OF APRIL 2024. ATTENDEES DECIDED, THAT THIS ISSUE IS WITHIN SCOPE OF CAPA TW#(B)(4) THAT IS IN INVESTIGATION PHASE. AS A CONTAINMENT ACTION STOP SHIPMENT WAS INITIATED. LOT IN QUESTION IS INCLUDED IN STOP SHIPMENT LIST. NO ANOTHER ACTION IS NEEDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE:(B)(4).

    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

    IT WAS REPORTED THEY HAVE BEEN USING THIS PRODUCT FOR THE PAST 2 YRS AND IT HAS WORKED WELL FOR HIM UP UNTIL THIS ORDER WHEN THE DAUGHTER SAID THEY GOT A DEFECTED BATCH. SHE THINKS SHE USED " TO CATH HER DAD BEFORE SHE NOTICED IT WAS DEFECTED FROM THESE 2 BOXES. HE DID NOT HAVE ANY HARM AFTER USE OF THIS ONE SHE USED "SAID AS IT WAS ABOUT 2 WEEKS AGO NOW AND HE IS FINE. SHE SAID SHE ALWAYS BURSTS THE WATER SACHET TO ACTIVATE IT AND "IN LESS THAN A MINUTES TIME" SHE COULD SEE THE WATER PERMEATING THROUGH TURNING THE PAPER BACKING DARK AND "OZZING ALONG THE BACKSIDE" OF THE PRODUCT ON THESE WITH DEFECT. SHE SAID THE TOP PULL TAB WOULD TEAR OFF TOO AS SHE TRIED TO PEEL IT OPEN SO SHE HAD TO POKE THROUGH THE PACKAGING WITH HER FINGERS TO GET THE CATHETER OUT. SHE SAID SHE DID NOT FEEL COMFORTABLE USING THESE WITH DEFECT AFTER SHE REALIZED IT, THINKING IT WOULD PUT HIM AT RISK FOR INFECTION WITH THE PERMEABILITY OF THE PAPER BEING THE WAY IT WAS. SHE DID NOT USE ANYMORE ON HIM." SHE SAID "THE PAPER DID NOT FEEL OR LOOK DIFFERENT THAT SHE COULD TELL ON THESE DEFECTED ONES COMPARED TO OTHERS WITHOUT DEFECT. SHE SAID SHE TRIED A FEW DIFFERENT ONES FROM THE 2 BOXES SHE HAD OF THAT LOT AND THEY WERE ALL DOING THAT." PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470780 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421910 3C01306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown