BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLE CATH

    MDR report key: 10037131 · Received May 7, 2020

    Report

    Report Number
    3005778470-2020-00117
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    GBM
    PMA / PMN Number
    K161344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.4: DEVICE MANUFACTURE DATE CORRECTED FROM 04/25/2019 TO 05/02/2019. A PHOTO WAS RECEIVED BUT, IT IS NOT POSSIBLE TO EVALUATE POSITION OF CONNECTOR INDICATOR AGAINST BENT TIP OF CATHETER BASED ON THE PICTURE. BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN FOLLOWING: WHOLE PRODUCTION AND PACKAGING PROCESS HAVE BEEN DONE IN COMPLIANCE WITH PRODUCT SPECIFICATIONS FOR 20 MALE COUDE (TIEMANN) CATHETERS ¿ GENTLECATH LOW-FRICTION. THE URINARY CATHETERS WERE MANUFACTURED UNDER SYSTEMS APPLICATION AND PRODUCTS (SAP) MATERIAL IDENTIFICATION NUMBER 1718777 AND MANUFACTURING LOT NUMBER 9D03861. LOT NUMBER 9D03861 WAS STERILIZED UNDER STERILIZATION BATCH - 25 190513, 24 190515, 26 190515, 26A190517, 26A190519 AND RELEASED BASED ON THE REVIEW OF RESULTS OF STERILIZATION. LOT NUMBER 9D03861 WAS PACKED IN PEEL PACKS ON MAY 02 ¿ 05 2019 IN CENTER C2 ON PACKAGING MACHINE P009, TOTAL LOT AMOUNT (B)(4) PIECES. THE CATHETERS WERE ASSEMBLED UNDER SUBASSEMBLY LOTS 9D03857AND 9D00129 AT MACHINE A097 IN APRIL 2019 ACCORDING TO THE PROCESS INSTRUCTIONS. ACCORDING TO THE PROCESS INSTRUCTIONS THE POSITION OF CONNECTOR INDICATOR AGAINST BENT TIP OF CATHETER IS CHECKED BY TECHNICIAN DURING ORDER SET UP- TWO PIECES (2PCS.) FROM EACH MOULDING STATION AND THEN 100% VISUAL INSPECTION WITH FOCUS ON TIEMMAN INDICATOR POSITION WAS CARRIED OUT BY TWO OPERATORS ACCORDING TO TESTING METHODS. ACCORDING TO RELEVANT DRAWING THE POSITION OF CONNECTOR INDICATOR VERSES TIP BENDING COULD BE IN THE RANGE 0°- 45° IN BOTH DIRECTIONS. THE CLAIMED 30 DEGREES MISALIGNMENT (POSITION OF THE COUDE TIP AGAINST INDICATOR) IS WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS, PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY OF THIS NATURE HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE MENTIONED LOTS. THE BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. DURING PRODUCTION OF THE LOTS ON THE MACHINE A097 THERE WERE TWO OPERATORS. BOTH OPERATORS PERFORMED VISUAL INSPECTION. MACHINE A097 HAD VISION SYSTEM THAT WAS NOT VALIDATED AT THE TIME OF LOT PRODUCTION. THE KEY POINT FOR INSTALLATION AND SETTING VISION SYSTEM IS TO PROVIDE A CONTROL OF ALL CATHETERS FOCUS ON CATHETERS FAILURE: - EYELET NO PUNCH, - HANGNAIL LEFT IN EYELETS, - POSITION OF CONNECTOR INDICATOR AND BENT TIP OF CATHETER. VISION SYSTEM HAS TO REJECT EVERY CATHETER WITH AT LEAST OF ONE FAILURE MENTIONED ABOVE. VALIDATION OF THE POSITION OF CONNECTOR WAS IN SCOPE WITH THE CHANGE CONTROL RECORD (CCR) WHICH WAS FOCUSED ON VALIDATION OF VISION SYSTEM FOR GENTLECATH GLIDE TIEMANN CATHETERS. THE CHANGE CONTROL RECORD WAS SIGNED ON DECEMBER 19, 2019. THE VISION SYSTEM ALLOWS TO PRODUCE CATHETERS WITHOUT THE NEED FOR A SECOND OPERATOR. A QUERY WAS RUN AGAINST MATERIAL NUMBER 1718777 FOR THE MALFUNCTION CODE FOR INCORRECT TIP ALIGNMENT (RELATIVE TO MARKINGS) WHICH, YIELDED ONE OCCURRENCE FROM NOVEMBER 2016. 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 10 OF 10. 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 THAT THE CATHETER COUDE TIP IS MISALIGNED WITH THE INDICATOR. THE END USER REPORTS "HE USES INDICATOR TO POSITION COUDE TIP AT CORRECT ANGLE FOR INSERTION. WITH MISALIGNED INDICATORS, HE IS UNABLE TO POSITION CORRECTLY, SO WHEN INSERTING, HE DOES NOT KNOW THE POSITION OF THE COUDE TIP UNTIL HE HITS RESISTANCE. HE USED ONE OF THE CATHETERS AND EXPERIENCED PAIN DURING INSERTION. HE THEN DETERMINED THAT THEY WERE MISALIGNED. IT WAS STATED THAT ¿HE HAD A TOTAL OF TEN AFFECTED WITH TWO THAT WERE OFF BY ABOUT 30 DEGREES AND EIGHT THAT WERE MISALIGNED TO A LESSER DEGREE.¿ HE WAS ADVISED NOT TO USE THESE PRODUCTS. THE END USER DID NOT SEEK MEDICAL ATTENTION. A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS SUBMITTED BY THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500377 GENTLE CATH CATHETER, URETHRAL GBM UNOMEDICAL S.R.O. 421910 9D03861

    Patients

    Seq Age Sex Outcome Treatment
    1