BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHER-I-BRONCH ACCESSORY PACK

    MDR report key: 4180365 · Received October 15, 2014

    Report

    Report Number
    3003898360-2014-00828
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS NOT RETURNED FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE CONNECTOR WAS BROKEN. IT IS UNK WHEN THE ALLEGED DEFECT WAS DISCOVERED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654035 HUDSON SHER-I-BRONCH ACCESSORY PACK ENDO- BRONCH ACCESSORY PACK BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1