BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3912423 · Received May 13, 2014

    Report

    Report Number
    2936999-2014-00434
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED, IF THE SAMPLE IS RECEIVED A SUMMARY OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON INFORMATION FROM COMPLAINT TRACKING SYSTEM, RECEIVED SAMPLE, PROVIDED PICTURE AND MANUFACTURING CONTROLS,THE FOLLOWING FACTS ARE CONCLUDED: THE FAILURE MODE WAS CONFIRMED IN THE RECEIVED SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE, A DOCTOR FELT STRONG RESISTANCE WHEN AIR WAS INJECTED IN THE CUFF. CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285630 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN 13D1102JZX

    Patients

    Seq Age Sex Outcome Treatment
    1