BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE CATH

    MDR report key: 9535735 · Received December 31, 2019

    Report

    Report Number
    3005778470-2019-00183
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 1, 2019
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE URINARY CATHETERS IN QUESTION WERE PRODUCED IN ACCORDANCE WITH PRODUCT SPECIFICATION. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE URINARY CATHETERS WERE MANUFACTURED UNDER SYSTEM APPLICATION PRODUCTS (SAP) MATERIAL IDENTIFICATION 1718772 AND MANUFACTURING LOT NUMBER 8G00725 IN AMOUNT 14,400 PIECES (PCS). THE CATHETERS WERE PACKED IN PEEL PACKS (POUCH) IN JULY 2018 ON PACKAGING MACHINE P009. LOT WAS STERILIZED UNDER STERILE LOTS 26A180709, 24 180710, 25 180710. THE PACKAGING PROCESS RUN ACCORDING TO THE PROCESS INSTRUCTIONS. PEEL TEST OF CATHETERS IS CARRIED OUT ACCORDING TO TESTING METHODS (TM)AND G805066. IT IS A PART OF IN PROCESS INSPECTION. REVIEW OF THE DEVICE HISTORY RECORDS (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 PROCESS OF THE MENTIONED LOT. BASED ON THE PICTURE RECEIVED THE DEFECT WAS CONFIRMED. THE PACKAGING PAPER OF THE PEEL PACK TORE. PEEL PACK PAPER USED FOR PACKING OF GLIDE CATHETERS IS MORE WAXED THEN PAPER USED FOR STANDARD PRODUCTS. THEREFORE, THE PAPER TENDS TO BE STICKY WITH THE FOIL AND THEREFORE IT COULD CAUSE LITTLE DIFFICULTIES TO OPEN THE PEEL PACK. THEN A MODIFICATION OF SEALS ON THE PACKAGING MACHINE P009 WERE IMPLEMENTED TO IMPROVE OPENING OF PEEL PACKS. NEW SEALS WERE AFTER TESTING AND CONFIRMATION OF POSITIVE RESULTS, IMPLEMENTED INTO PRODUCTION IN MARCH 2019. LOT IN QUESTION WAS PRODUCED BEFORE THE SEAL MODIFICATION. NO ANOTHER COMPLAINT WAS RECEIVED ON THE LOT. 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: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE 6 OF 30. (B)(6). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY THAT THE PRODUCT "WRAPPING PAPER TEARS OPEN, IMPOSSIBLE TO TAKE THE PROBE, WITHOUT COMPROMISING THE ASEPSIS". THE PRODUCTS WERE NOT USED ON OR BY PATIENTS. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE SUBMITTED BY THE COMPLAINANT. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331247 GENTLE CATH CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421911 8G00725

    Patients

    Seq Age Sex Outcome Treatment
    1