BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPY IN/OUT FLOW TUBE SET

    MDR report key: 2299220 · Received October 18, 2011

    Report

    Report Number
    1017294-2011-00043
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Report Date
    October 5, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INTERNAL AUDIT, 200 PACKAGES WERE VISUALLY INSPECTED AND NO CREASES ON THE SEAL WERE FOUND. TWENTY (20) PACKAGES WERE TESTED FOR DYE PENETRATION AND ALL PASSED THE TEST. ANOTHER 20 PACKAGES WERE OPENED TO VISUALLY INSPECT THE SEALED AREA AND ALL PASSED THE INSPECTION. ALL 40 OF THESE PACKAGES WERE SCRAPPED. AFTER THE INSPECTION AND TESTING PROCESS, THE OTHER 160 PACKAGES WERE RELEASED FOR DISTRIBUTION. BASED ON THIS FINDING, THIS IS AN ISOLATED EVENT. AN INVESTIGATION OF THE MANUFACTURING PROCESS REVEALED THAT THE SEALER MACHINE HAS A DETECTION SYSTEM THAT DETECTS WHEN THE SEAL HAS WRINKLES THAT CAUSE CREASES IN THE SEAL. THE DETECTION SYSTEM DETECTS FAILED POUCHES AT ALL TIMES. WHENEVER A WRINKLE IS DETECTED THE SEALER STOPS, AN ALARM SOUNDS, AND RETURNS THE POUCH. THE MANUFACTURING PROCEDURE (B)(4), INSTRUCTED THE OPERATOR TO OPEN THE DETECTED FAILED POUCH AND RE-SEAL THE TUBE SET IN A NEW POUCH. HOWEVER, THE MP DOES NOT INDICATE WHEN TO DO IT. THE OPERATOR USED TO PUT ASIDE THE DETECTED POUCHES TO DO THE RE-SEAL LATER. THIS PRACTICE COULD HAVE CAUSED THE REPORTED PROBLEM, IN THAT DURING THE OPERATION CHANGE OVER BETWEEN OPERATORS, WHICH IS DONE EVERY HOUR, THE NEXT OPERATOR COULD HAVE MISTAKENLY TAKEN ONE OF THE REJECTED POUCHES AND PASSED IT AS A GOOD ONE. AS A RESULT OF THIS FINDING, THE (B)(4) WAS REVISED AS OF (B)(4) 2011, TO INDICATE THAT WHENEVER THE SEALER DETECTS A FAILED POUCH, IT SHOULD BE OPENED AND THE TUBE SET MUST BE RE-SEAL IN A NEW POUCH IMMEDIATELY TO AVOID THE BAD POUCH BEING PASSED AS A GOOD ONE. IN ADDITION, A FORM TO RECORD WHEN A BAD POUCH IS DETECTED WILL BE IMPLEMENTED TO MATCH POUCHES DETECTED AND THE POUCHES THAT SCRAPPED. THIS PROCESS WILL CREATE A RECORD TO ASSURE NO POUCHES WITH BAD SEAL CAN BE PASSED AND SENT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: CONMED LINVATEC RECEIVED TWO 10K150 FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. VISUAL EXAMINATION OF THE RETURNED PACKAGES FOUND ONE TUBING SET HAD A MINOR CREASE IN THE SEAL, AND THE OTHER TUBING SET HAD AN OBVIOUS CREASE, WHICH EXTENDED THROUGH THE ENTIRE SEAL WIDTH. BOTH TUBING SETS WERE FORWARDED TO R&D TEST LAB FOR DYE LEAK TESTING. THE TUBING SET WITH THE OBVIOUS CREASE THAT EXTENDED THROUGH THE SEAL WIDTH FAILED LEAK TESTING. THE OTHER TUBING SET PASSED LEAK TESTING. (B)(4). AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE ROOT CAUSE OF THIS REPORTED PROBLEM AND A FOLLOW-UP WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, "CREASE" WAS FOUND IN THE SEALING AREA OF THIS STERILE PACKAGE CONTAINING THE 10K150 ARTHROSCOPY IN/OUT FLOW TUBE SET. TESTING RESULT CONFIRMED THE RETURNED PACKAGE DID FAIL LEAK TEST ON (B)(6) 2011. THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPY IN/OUT FLOW TUBE SET INTRODUCTION/DRAINAGE CATHETER & ACCESS HRX CONMED LINVATEC 1103175

    Patients

    Seq Age Sex Outcome Treatment
    1