BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH GLIDE

    MDR report key: 21078830 · Received January 6, 2025

    Report

    Report Number
    3005778470-2025-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Report Date
    January 2, 2025
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    UDI-DI
    30768455143543
    PMA / PMN Number
    K181206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER GENTLECATH GLIDE MALE CH14 IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID: 1713714 AND MANUFACTURING LOT#: 3M00779 IN CENTER C2 ON PACKAGING MACHINE P006 IN AMOUNT (B)(4) PIECES. THE CATHETER USED IN PACKAGING LOT#: 3M00779 WERE PRODUCED UNDER LOT#: 3L02636 (PRODUCED ON MACHINE A116 IN NOVEMBER 2023). NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT. ACCORDING TO G805311 V. 27.0, SEC. 5.12.4. VISUAL AND TACTILE CHECK OF EYELETS ¿ NO THREADS AND/OR FRAYED EDGES, SLUGS/ PUNCH OUTS ARE ALLOWED AND EYELETS HAVE TO BE SMOOTH. CHECK OF EYELETS IS PROVIDED ACCORDING TO TM-356, VER.3.0 AND TESTS RESULTS HAVE BEEN RECORDED IN G905311 FORM 3. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. THE PROCESS PARAMETERS WERE ADJUSTED WITHIN THE VALIDATED WINDOW. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT AND OF THE MENTIONED ISSUE. NO COMPLAINT WAS RECEIVED ON LOT#: 3M00779 AND MALFUNCTION CODE: UCA-PMC07.02 CATHETER SHAFT, BALLOON, TIP OR EYELETS TOO ROUGH/JAGGED EDGES OR TOO SHARP. THIS COMPLAINT WAS PRESENTED TO THE COMPLAINT REVIEW BOARD ON JANUARY 16, 2024. BASED ON THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO CONFIRM THE ISSUE. ATTENDEES DECIDED THAT NO FURTHER ACTIONS ARE REQUIRED. OPERATORS WILL BE RETRAINED ACCORDING TO G708002 EDUCATION AND TRAINING OF PRODUCTION PERSONNEL AND THE ISSUE WILL BE PRESENTED TO OPERATORS ACCORDING TO WI-001366 QA DATA VISUALIZATION. 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

    DEVICE 2 OF 3. 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 STATES HE "CATHS 8-9 X A DAY FOR RETENTION. HE WAS BORN WITH A BLADDER THAT HAS MANY CHAMBERS HE SAID AND HAS TO CATH FOR RETENTION AS ALL URINE DOES NOT DRAIN FROM EACH CHAMBER. HE SAID WHILE HE WAS TOLD HY MDS THAT HE WAS BORN WITH THIS, IT WAS ONLY DISCOVERED ABOUT 8-9 YRS AGO WHEN HE WAS IN HIS 50S POST COLONOSOPY WHEN HE COULD NOT VOID AND HAD TO START IC. HE STATES HE HAS USED A VARIETY OF DIFFERENT CATHETERS IN THE REMOTE PAST BUT PREFERS THE GC GLIDE MOST OF ALL AND HAS BEEN USING IT FOR THE PAST 4 YRS. PREPS THEM PER IFU. HE SAID THAT AT TIMES HE FEELS THERE IS A "BLIP IN QUALITY CONTROL" AND THAT HE FEELS WHEN THIS CATHETER IS IN HIM THAT THERE IS A "BUR ON THE EYELETS OR A SHARP EDGE" TO THE EYELETS. HE SAID WHEN THIS OCCURS IT IS USUALLY 2 OR 3 ON THE SAME PERFORATED STRIP "BACK TO BACK" OF A FEW CATHETERS TOGETHER IN A BOX. WHEN HE FINDS 2 OR 3 LIKE THIS IN A BOX HE IS USING HE JUST "TRASHES IT" ALL AS HE IS TOO SCARED TO USE ANYMORE OF THIS BOX AND HAS TO GO TO A NEW BOX WHERE THE PROBLEM IS NOT PRESENT. HE SAID THAT IT IS JUST SOME AND DOESN'T HAPPEN ALL THE TIME, JUST ON OCCASION. THERE IS NO WAY FOR HIM TO KNOW IF THE EYELETS ARE AFFECTED UNTIL HE HAS THE CATHETER IS IN HIM AND HE SAID THE AFFECTED EYELETS WILL CUT HIM ON EXTRACTION. HE WILL THEN NOTE BLOOD ON THE CATHETER UPON EXTRACTION AND THEN THE NEXT DAY A FEW SMALL BLOOD CLOTS WILL PASS BEFORE DISSIPATING ON IT'S OWN. HE IS NOT ON BLOOD THINNERS. HE DOES FEEL SOME RESISTANCE AT ABOUT 6 - 7 INCHES IN AND HE ALWAYS HAS TO ROTATE AND SHIFT/ MOVE HIS CATHETER OUT AND IN AT THE ENTRANCE TO HIS BLADDER TO GET TO ALL THE CHAMBERS HE HAS IN HIS BLADDER TO DRAIN. HE IS NOT SURE IF HIS PROSTATE IS ENLARGED BUT KNOWS HIS PSA IS ALWAYS VERY HIGH WHEN IT IS CHECKED AND FOLLOWS UP WITH HIS MD REGULARLY BUT STATES HE NEVER GETS MORE THAN 5 MIN WITH HIS UROLOGIST. HE SAID HE OFTEN GETS UTIS AND YEAST INFECTIONS THROUGHOUT THE YEARS, TREATED BY HIS MD DUE TO HIS CONDITION OF HIS IRREGULAR BLADDER NOT FULLY DRAINING BUT DOES NOT SEE A CAUSE AND EFFECT OR DIRECT CONNECTION WITH THIS DEFECT HE IS REPORTING. HE REPORTED THIS AS HE SAID HE WANTS FOR OUR QUALITY TEAM TO BE AWARE AS HE FEELS THIS CONCERN WITH THE EYELETS IS AN "ISSUE IN PRODUCTION" AND HE HAS BACKGROUND HAVING BEEN A PHD PROFESSOR FOR "SURFACE PHYSICS" HE SAID. HE HAS NEVER FELT THE EYELETS WITH HIS HANDS UPON REMOVAL OF ONES HE BELIEVES ARE SHARP AS HE SAID HE SAID HIS FINGERS DON'T FEEL VERY WELL/ HAS SENSORY ISSUES ON HIS HANDS. HE HAS DISCARDED ALL OF THEM HE HAS USED AND FOUND THIS WAY HOWEVER HE SAID HE DOES HAVE THE REMAINING NEW CATHETERS IN THE BOX WHERE HE FOUND THE LAST 3 OF THE LOT HE IS REPORTING IN THIS CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949618 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421567 3M00779 30768455143543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male