BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10K/24K ARTHROSCOPY INFLOW TUBE SET

    MDR report key: 3222671 · Received July 12, 2013

    Report

    Report Number
    1017294-2013-00030
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: CONMED LINVATEC RECEIVED ONE PACKAGE CONTAINING 10K100 TUBING SET FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PACKAGE/POUCH BY THE PACKAGING ENGINEER CONFIRMED THERE WAS NO EVIDENCE OF ADHESIVE PRESENT, OR THAT THE PACKAGE HAD BEEN PLACED IN THE SEALER AT ALL. THE OPEN PACKAGE WAS VERY OBVIOUS TO THE CUSTOMER, WHICH PROMPTED THE COMPLAINT NOTIFICATION AND RETURN OF THE ITEM AND ITS PACKAGING FOR EVALUATION. (B)(4). AN INVENTORY REVIEW OF THIS LOT WAS PERFORMED, AND THERE ARE NO REMAINING UNITS WITH THIS LOT NUMBER IN STOCK. (B)(4). THIS MADE THE FAILURE RATE FOR THIS DEVICE FAMILY IS (B)(4). RISK EVALUATION SHOWS THIS FAILURE CONTINUES TO BE AT AN ACCEPTABLE RISK LEVEL. TO DATE, NO PATIENT INJURIES HAVE BEEN REPORTED FOR THIS DEVICE THAT WAS RELATED TO THE REPORTED PROBLEM. AN INVESTIGATION WAS GENERATED TO ADDRESS THIS REPORTED PROBLEM AND A FOLLOW-UP WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED. AS WITH ALL MEDICAL DEVICES, EXAMINATION OF THE PRODUCTS OCCURS MULTIPLE TIMES PRIOR TO USE (SHIPPING/RECEIVING, DISTRIBUTION, STORAGE AND IMMEDIATELY PRIOR TO USE). GOOD CLINICAL PRACTICE WOULD INCLUDE EXAMINATION AND VERIFICATION OF THE ORIGINAL PACKAGING AND ITS LABELING TO ENSURE BOTH ARE INTACT. ADDITIONALLY, THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) WARNS: IF PACKAGING HAS BEEN OPENED/DAMAGED OR ALTERED, DO NOT USE THE PRODUCT AND CONTACT THE MANUFACTURER IMMEDIATELY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE UNSEALED POUCH/PACKAGE REVEALED THAT THIS PARTICULAR PACKAGE DID NOT PASS THROUGH THE SEALING PROCESS, AS THERE WAS NO EVIDENCE OF THE ADHESIVE PRESENT. IT WAS FURTHER DETERMINED THAT THIS NONCONFORMANCE IS DUE TO AN OPERATOR ERROR FOR NOT FOLLOWING THE WORK FLOW WHEN A PROCESS DEVIATION OCCURRED DURING THE MANUFACTURING PROCESS FOR THIS LOT OF PRODUCT. THIS PACKAGE WAS INADVERTENTLY MISSED FROM BEING PLACED IN THE SEALING STATION FOR PROCESSING AND SEALING, AND WAS MISTAKENLY PACKAGED FOR PRODUCTION RELEASE. AS A RESULT OF THIS FINDING, ADDITIONAL TRAINING WAS PROVIDED TO ALL PERSONNEL INVOLVED IN THE (B)(4) MANUFACTURING PROCESS APPLICABLE TO THE SPECIFIED WORK INSTRUCTIONS. IN ADDITION, THIS COMPLAINT WAS BROUGHT TO THEIR ATTENTION AND POTENTIAL CONSEQUENCES WERE DISCUSSED TO FURTHER REINFORCE THE GMP REQUIREMENTS AND THE IMPORTANCE OF FOLLOWING THE WORK INSTRUCTIONS IN ORDER TO PREVENT THIS NONCONFORMANCE FROM RECURRING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE RESTOCKING OF THE 10K100 ARTHROSCOPY INFLOW TUBE SETS, IT WAS DISCOVERED THAT ONE OF THE PACKAGES WAS NOT SEALED. SINCE THE ANOMALY WAS NOTICED WHILE RESTOCKING, THE PRODUCT WAS NOT USED AND THUS THERE WAS NO PATIENT INVOLVEMENT. THE OTHER NINE (9) PACKAGES IN THE SAME BOX WERE INSPECTED WITH NO ABNORMALITIES NOTED. THESE WERE PLACED IN STOCK FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323225 10K/24K ARTHROSCOPY INFLOW TUBE SET ARTHROSCOPE HRX CONMED LINVATEC 10K100 1304234

    Patients

    Seq Age Sex Outcome Treatment
    1