BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 3720875 · Received March 13, 2014

    Report

    Report Number
    3006389770-2014-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAID DEVICE OR ITS PART IS NOT AVAILABLE FOR ANY EVALUATION NEITHER THE LOT OF THE DEVICE IS AVAILABLE. FROM THE INFORMATION AVAILABLE FROM (B)(4), THEY RECEIVED BACK 3 DEVICES FROM THE SAID HOSPITAL. THESE WERE HAVING LOT NUMBERS AS BELOW, LOT NO: MD 011, EXPIRY DATE: 03/2011; LOT NO: MD 035, EXPIRY DATE: 09/2013; LOT NO: MD 039, EXPIRY DATE: 11/2013. IT APPEARS THAT THE DEVICE USED WAS PROBABLY OF AN EXPIRED LOT AVAILABLE AT THE SAID HOSPITAL. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150653 ENDOTRACHEAL TUBE INTRODUCER ET TUBE INTRODUCER BSR MEDITEC DEVICES

    Patients

    Seq Age Sex Outcome Treatment
    1