BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSBRONCHIAL ASPIRATION NEEDLES

    MDR report key: 1021930 · Received March 28, 2008

    Report

    Report Number
    9710641-2008-00044
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CONMED CORP, SEISA
    Product Code
    BTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "NO LOT NUMBER WAS PROVIDED, AS SUCH A DHR REVIEW COULD NOT BE PERFORMED FOR A SPECIFIC LOT, HOWEVER, A RETENTION SAMPLE-BASED REVIEW WAS PERFORMED FOR THE FIRST HALF OF THE YEAR OF 2007; NO EVIDENCE OF PRODUCT MIXTURE WERE FOUND FOR CATALOG NUMBERS MW-122 AND MW-522." THE ABOVE STATEMENT WAS MADE ON A WANG NEEDLE INVESTIGATION REPORT DATED 2-29-2008.

    Description of Event or Problem · 1

    IT WAS REPORTED "LAST TWO WEEKS WHEN I REQUESTED A MW-122 AND A MW-522 NEEDLE, THE PACKAGE OF MW-122 NEEDLE CONTAINS A NEEDLE OF MW-522."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSBRONCHIAL ASPIRATION NEEDLES WANG CYTOLOGY NEEDLES BTG CONMED CORP, SEISA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1