BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLECATH GLIDE

    MDR report key: 10864386 · Received November 18, 2020

    Report

    Report Number
    3005778470-2020-00202
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 2, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOTH COMPLAINTS WERE RECEIVED FROM THE SAME CUSTOMER- (B)(6), LOT: 8KR4798 AND (B)(6), LOT: 8J01852. NO OTHER COMPLAINT OF THIS NATURE ON THE GLIDE CATHETERS HAS BEEN RECEIVED YET. THE CATHETERS LOT: 8J01852 WERE PACKED IN PEEL PACKS ON SEPTEMBER 13TH 2018 IN AMOUNT 9600 PCS ON PACKAGING MACHINE P009. THE RAW CATHETERS WERE ASSEMBLED ON MACHINE A099 UNDER SUB- ASSEMBLY LOT: 8J00389 . ALL CORRECT RAW MATERIALS WERE USED DURING SUB-ASSEMBLY LOT AND THE FINAL LOT PRODUCTION. THE CATHETERS LOT: 8KR4798 WERE PACKED IN PEEL PACKS ON NOVEMBER 2-5TH 2018 IN AMOUNT 96 000 PCS ON PACKAGING MACHINE P009. THE RAW CATHETERS WERE ASSEMBLED ON MACHINE A099 UNDER SUB- ASSEMBLY LOT: 8K04270 . ALL CORRECT RAW MATERIALS WERE USED DURING SUB-ASSEMBLY LOT AND THE FINAL LOT PRODUCTION. 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 RELATED TO THE ISSUE REPORTED HAD BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF BOTH MENTIONED LOTS. 65 PCS CLAIMED SAMPLES LOT: 8KR4798 WERE RECEIVED. VISUAL INSPECTION CONFIRMED THE ISSUE REPORTED. (B)(4) ADDITIONAL SAMPLES / ONE MU FROM EACH LOT / LOTS: 8J01852 AND 8KR4798 WERE PROVIDED FROM OUR DISTRIBUTION CENTER FOR EVALUATION. THE ISSUE WAS CONFIRMED. SMALL WHITE PARTICLES WERE OBSERVED THERE TOO. BECAUSE THE ISSUE REPORTED SEEMS TO BE NOT HAVE ANY CONNECTION TO PRODUCTION PROCESS ITSELF. CRB HELD ON NOVEMBER 27TH 2020 DECIDED TO ASKED R&D REPRESENTATIVE TO CARRY OUT THE RCI. RCI IS BEING CARRIED OUT UNDER EVENT (B)(4). JMK INVESTIGATION RESULTS THE RCI WAS FINISHED WITH CONCLUSION: "ON THE BASE OF DISCUSSION , WE CAN CONCLUDE THAT HYDROPHILIC MASTER BATCH MIGRATE ON THE SURFACE OF THE TUBE, WHAT IS NATURE FUNCTION OF GENTLECATH GLIDE INTERMITTENT CATHETERS. THE "FLOATIES" OR WHITE FLAKY MATERIAL OBSERVED BY PATIENT AND REPORTED. IT IS HYDROPHILIC MATERIAL SEATING ON THE TUBE SURFACE. THIS MATERIAL CAN BE NOTICE AS A "FLOATIES¿ AFTER WATER SACHET BURST. BECAUSE BIOCOMPATIBILITY EVALUATION FOR GENTLECTAH GLIDE CATHETERS PROVIDES EVIDENCE ABOUT THE SAFETY USE OF CATHETERS WE CONCLUDE THE REPORTED ¿WHITE FLOATIES¿ DO NOT REPRESENT SAFETY AND QUALITY ISSUE FOR CATHETER USAGE." THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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.

    Additional Manufacturer Narrative · 1

    MDR / DEVICE 1 OF 1. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USER AND HER HUSBAND THAT THE WIFE WAS USING "GENTLECATH GLIDE 10 FRENCH MALE, STRAIGHT TIP CATHETER." THE COMPLAINANT REPORTS THAT THEY NOTED "FLOATIES" OR WHITE FLAKY MATERIAL WITHIN THE CATHETER PACKAGING AFTER THE WATER SACHET WAS BURST. IT IS UNKNOWN IF THE "FLOATIES" CAME FROM THE WATER SACHET OR FROM SOMEWHERE ELSE WITHIN THE PACKAGING." THE END USER WAS UNSURE IF IT IS OKAY TO USE THE PRODUCT AND DECIDED NOT TO, END USER DID EXPRESS BEING "VERY DISTRESSED" FROM HAVING THIS ISSUE. THE CONSUMER HAS USED SOME OF THE AFFECTED CATHETERS AS HE REPORTS THEY DISCOVERED TODAY THAT SHE HAS NO OTHER CATHETERS TO USE. AT THIS TIME, NO HARM REPORTED BUT THEY ARE CONCERNED ABOUT USING THE CATHETERS DUE TO THE CONSUMER¿S HISTORY OF FREQUENT URINARY TRACT INFECTIONS (UTI). SHE CATHETERIZES SIX- SEVEN TIMES DAILY DUE TO URINARY RETENTION DUE TO INTERSTITIAL CYSTITIS. THE CONSUMER IS GOING IN TOMORROW TO CHECK FOR A UTI. HE STATES THAT SHE IS VERY DISTRAUGHT OVER THE ¿FLOATIES¿ AND HER PHYSICIAN DECIDED TO BRING HER IN TO CHECK FOR A UTI AS A RESULT. ADDITIONAL INFORMATION RECEIVED 06 NOVEMBER 2020 FROM COMPLAINANT INFORMING THAT ¿THEY REMOVED A SACHET FROM A PACKAGE AND OPENED IT INTO A GLASS AND IT WAS CLEAR WITH NO ¿FLOATIES¿ OR FLAKES. THEY THEN BURST THE SACHET WITHIN THE CATHETER PACKAGE AND WAITED 30 SECONDS AND THEN POURED THIS LIQUID INTO THE JAR AND THE JAR HAD THE FLOATIES AND WAS CLOUDY. FOR COMPARISON, THEY DID THE SAME THING WITH A NEW LOT NUMBER OF CATHETERS THAT THEY JUST RECEIVED FROM THE DISTRIBUTOR WITH THE SAME REFERENCE (REF)AND IT WAS CLEAR WHEN POURED FROM THE PACKAGE AFTER THE SACHET WAS BURST WITHIN THE PACKAGE.¿ THE CUSTOMER HAS BEEN EXPERIENCING ¿URETHRAL IRRITATION¿ THAT SHE NOW BELIEVES IS RELATED TO THIS ISSUE. THE COMPLAINANT WAS NOT ABLE TO STATE WHEN THE IRRITATION BEGAN, IF IT IS CONTINUOUS OR INTERMITTENT. HE WAS UNABLE TO DESCRIBE WHAT ¿IRRITATION¿ MEANT¿IF IT WAS REDNESS, AN OPEN AREA OR SWELLING. HE STATES THAT THEY ¿SENT A NOTE TO THE PHYSICIAN¿ ABOUT IT AND THE PHYSICIAN HAD NO RECOMMENDATION AND NO PRESCRIPTIONS WERE PROVIDED. THE CUSTOMER TREATS THE AREA WITH ICE COMPRESSES. ADDITIONAL INFORMATION WAS RECEIVED ON 09 NOVEMBER 2020, FROM THE COMPLAINANT INFORMING THAT A URINARY TRACT INFECTION HAD BEEN DIAGNOSED. URINE CULTURE RESULTS, >100,000 CFU/ML KLEBSIELLA PNEUMONIAE. THE END USER¿S URETHRA IRRITATION WAS FINALLY REPORTED TO HER PRIMARY PHYSICIAN IN EARLY OCTOBER AFTER LONG BOUTS OF DISCOMFORT. PHOTOGRAPHS RECEIVED FROM COMPLAINANT INDICATING THE REPORTED COMPLAINT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328083 GENTLECATH GLIDE CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421565 8J01852

    Patients

    Seq Age Sex Outcome Treatment
    1