BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROENTEROLOGY-PAED FEEDING

    MDR report key: 7866050 · Received September 11, 2018

    Report

    Report Number
    3005778470-2018-00023
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FPD
    PMA / PMN Number
    K896734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(6) A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: FEEDING CATHETERS IN QUESTION WAS MANUFACTURED UNDER REF CODE 12024182, SAP MATERIAL ID 1300238 AND MANUFACTURING LOT # 6M02060. THE CATHETERS WERE ASSEMBLED UNDER SUBASSEMBLY LOT 6M02030 ON MACHINE A036 ON 20 -(B)(6) 2016 AND THEN PACKED IN PEEL PACKS (POUCH) UNDER LOT 6M02060 ON 8-9 JANUARY 2017 ON PACKAGING MACHINE P015. THE PRODUCTION PROCESS RUN ACCORDING TO THE PROCESS INSTRUCTION G905500 VER 25. THE PROCESS PARAMETERS WERE ADJUSTED WITHIN THE VALIDATED WINDOW GA05322 VER 8.0. THEN THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905703 V.38. LOT # 6M02060 WAS STERILIZED UNDER LOT 25 170112. THE RAW CATHETERS WERE PRODUCED ON MACHINE A036 AND WITHIN IN-PROCESS CONTROL 100% VISUAL INSPECTION WITH FOCUS ON THE PRESENCE OF VISUAL LUBRICANT REMAINING AND/OR COLOR DIFFERENCE OF CONNECTOR WAS CARRIED OUT ACCORDING TO G905500 SECTION 5.11 SUBSECTION 4 . RESULTS WERE FILLED IN IN RELEVANT FORM. 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 PROCESS OF THE MENTIONED LOT. A PHOTOGRAPH OF CLAIMED SAMPLE HAS BEEN PROVIDED AND EVALUATED. THE BROWN BLEMISH ON THE CONNECTOR IS VISIBLE. THE DEFECT REPORTED HAS BEEN CONFIRMED. THE SAMPLE DID NOT MEET REQUIREMENTS H805005 V.9.0 GENERAL QUALITY REQUIREMENTS FOR CATHETERS ;ATTACHMENT 9.4, SECTION 24 NO FOREIGN BODIES SUCH AS DIRT MARKS ,LUBRICANT ON THE CONNECTOR. NO ANOTHER COMPLAINT WAS RECEIVED ON LOT UNTIL NOW. THE UNOPEN ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. THE BROWN BLEMISH ON THE CONNECTOR WAS CONFIRMED BUT THE SOURCE OF THE BLEMISH WAS DETERMINED TO BE THE SUPPLIER PRODUCTION. THE SUPPLIER INVESTIGATION REVEALED THAT NOK FEEDING CONNECTOR FROM THE COMPLAINT WAS PRODUCED UNDER BATCH 308686. THE SUPPLIER PERFORMED REVIEW OF PRODUCTION DOCUMENTATION RELATED TO THIS BATCH AND FOUND OUT THAT DURING PRODUCTION OF THE LOT WAS REGISTERED ISSUE WITH OIL IMPURITIES ON THE ONE PART OF MOLDING TOOL. DUE TO THESE IMPURITIES, 4300 PIECES WERE REJECTED. ISSUE WAS CORRECTED BY TECHNICIAN IMMEDIATELY ON THE PLACE AND PRODUCTION CONTINUED AFTER REPEATED APPROVAL BY QC. AFTER ASSESSMENT OF RECEIVED NOK SAMPLE, THE SUPPLIER ASSUMED THAT DIRT/BROWN BLEMISH COULD BE RELATED TO PROBLEMS WITH OIL IMPURITIES REGISTERED DURING PRODUCTION OF ORDER 306686. NOK PART COULD BE RESULT OF INSUFFICIENT SORTING OR IT IS IN ANY WAY CONNECTED DIRECTLY TO OIL OCCURRENCE. PERFORMED INVESTIGATION INDICATE THAT DEFECT ON THE FEEDING CONNECTOR COULD BE RELATED TO RANDOMLY OCCURRENCE OF OIL IMPURITIES OBSERVED DURING PRODUCTION OF ORDER 308686. TECHNICAL PROBLEM WAS CORRECTED IMMEDIATELY DURING PRODUCTION ORDER BY TECHNICIANS. DURING PRODUCTION THE SUPPLIER CLEAN MOLDING TOOL AFTER EACH FINISHING OF ORDER AND BEFORE THE START OF EACH PRODUCTION THE QUALITY OF PRODUCED PARTS IS APPROVED BY QC. QUALITY OF PRODUCTION IS REGULARLY MONITORED BY OPERATOR AS WELL AS BY QC. 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

    (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 THAT THERE WAS "BROWN BLEMISH SHOWN IN THE TIP OF THE CONNECTOR." IT WAS FURTHER REPORTED THAT THE FEEDING TUBE PACKAGE WAS NOT OPENED AND NOT USED. PHOTOGRAPHS DEPICTING THE REPORTED ISSUE WERE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706779 GASTROENTEROLOGY-PAED FEEDING TUBE, FEEDING FPD UNOMEDICAL S.R.O. 12024182 6M02060

    Patients

    Seq Age Sex Outcome Treatment
    1