BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSBRONCHIAL ASPIRATION NEEDLES

    MDR report key: 1021929 · Received March 28, 2008

    Report

    Report Number
    9710641-2008-00043
    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

    IT WAS CONCLUDED, BASED ON RETENTION SAMPLE ANALYSIS, THAT SW-521 PRODUCTION LOT 0703071 WAS PRODUCED USING THE CORRECT COMPONENTS, BUT WITH A MISPRINTED HEAT SHRINK SLEEVE. EVEN THOUGH THE CORRECT LOT NUMBER WAS PRINTED ON THE HEAT SHRINK SLEEVE, IT WAS INCORRECTLY PRINTED WITH CATALOG NUMBER SW-121, INSTEAD OF SW-521. INCORRECTLY PRINTED CATALOG NUMBER ON HEAT SHRINK SLEEVE WAS DUE TO OPERATOR ERROR. SINCE THIS DEVICE WAS MANUFACTURED, THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN TAKEN: TRAINING OF MANUFACTURING PERSONNEL. THE OPERATION HAS BEEN ENHANCED SO THAT THE HEAT SHRINK OF THE NUMBERED SLEEVE IS A CONTROLLED LABELLING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED "JUST FINISHED A CASE AT HHC. I REQUESTED A SW-121 AND A SW-521 NEEDLE EACH. IT TRUED OUT THE PACKAGE OF 521 NEEDLE CONTAINS 121 NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSBRONCHIAL ASPIRATION NEEDLES WANG CYTOLOGY NEEDLES BTG CONMED CORP, SEISA 0703071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK