BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10K100 ARTHROSCOPY INFLOW TUBE SET

    MDR report key: 1931786 · Received December 9, 2010

    Report

    Report Number
    1017294-2010-00095
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: CONMED LINVATEC RECEIVED TEN (10) TUBING SETS FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM. VISUAL EXAMINATION OF THE 10 PACKAGES FOUND ONE PACKAGE DID HAVE A LARGE OPENING AT ONE END OF THE SEALED POUCH AND ONE OTHER PACKAGE HAS A SMALL OPENING IN THE UPPER LEFT HAND CORNER DUE TO THE SEAL BEING AT AN ANGLE RATHER THAN A STRAIGHT LINE ACROSS THE TOP OF THE PACKAGING. THERE ARE NO OTHER SIMILAR REPORTS RELATED TO THIS LOT NUMBER. 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

    OUR DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF THE INCOMING PRODUCTS, IT WAS NOTED THAT THE STERILE PACKAGES CONTAINING THE 10K100 ARTHROSCOPY INFLOW TUBE SETS WERE NOT PROPERLY SEALED. THE PRODUCT STERILITY WAS THEREFORE COMPROMISED. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10K100 ARTHROSCOPY INFLOW TUBE SET ARTHROSCOPE, ORTHOPEDIC HRX CONMED LINVATEC 1009073

    Patients

    Seq Age Sex Outcome Treatment
    1