BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24K100 ARTHROSCOPY OUTFLOW/SUCTION TUBE SET

    MDR report key: 1983338 · Received February 4, 2011

    Report

    Report Number
    1017294-2011-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    February 3, 2011
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FINDINGS: A VISUAL EXAMINATION OF THE RETURNED 24K100 TUBING SET PACKAGING FOUND THAT ONE END OF THE PACKAGING POUCH WAS OPENED. IT WAS ALSO NOTED THAT THE OPENED END OF THE PACKAGING HAD EVIDENCE OF TWO ATTEMPTS TO SEAL THE PACKAGE. FURTHER EVALUATION BY THE PACKAGING ENGINEER CONFIRMED THAT THERE HAD BEEN TWO ATTEMPTS TO SEAL THE PACKAGING. HOWEVER, BOTH SEALING ATTEMPTS WERE NOT SUCCESSFUL. 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

    THE CUSTOMER REPORTED THAT THE STERILE PACKAGE CONTAINING THIS 24K100 ARTHROSCOPY OUTFLOW/SUCTION TUBE SET WAS NOT SEALED. THE OPEN SEAL PACKAGE WAS DISCOVERED DURING SET UP. ANOTHER TUBING SET WAS USED AND THE CASE COMPLETED AS INTENDED. 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 24K100 ARTHROSCOPY OUTFLOW/SUCTION TUBE SET INTRODUCTION/DRAINAGE CATHETER AND ACCES HRX CONMED LINVATEC 24703-000

    Patients

    Seq Age Sex Outcome Treatment
    1