BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 6183464 · Received December 16, 2016

    Report

    Report Number
    2936999-2016-01078
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    HENEQUEN-RX
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE DEVICES WILL BE ENTERED IN THIS SINGLE COMPLAINT RECORD FOR PRODUCT WITH MULTIPLE DEVICES OF THE SAME LOT NUMBER. THERE IS NO EVIDENCE THAT THE CUSTOMER FOUND FIBER IN MORE THAN ONE PRODUCT. IF IT CAN BE CONFIRMED THAT MORE THAN 1 PRODUCT WAS FOUND WITH THE NOTED FAILURE (FIBER IN PACKAGE), THEN ADDITIONAL REPORTS WILL BE SUBMITTED AT THAT TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, FOREIGN MATERIAL SIMILAR TO A PIECE OF FIBER WAS FOUND CONTAINED IN THE PACKAGE OF THE ENDOTRACHEAL TUBE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ANY REQUIRED INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833587 MALLINCKRODT TAPERGUARD EVAC TRACHEAL 7.5 BTR HENEQUEN-RX 18875 16B0632JZX

    Patients

    Seq Age Sex Outcome Treatment
    1