BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3971287 · Received June 30, 2014

    Report

    Report Number
    2936999-2014-00576
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    BTR
    PMA / PMN Number
    K873461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, UPON REMOVING A LASER ORAL TRACHEAL TUBE, THE PHYSICIAN FOUND A HOLE AT THE DISTAL CUFF, AND OBSERVED THAT THE SALINE SOLUTION HAS LEAKED. NO RECANNULATION OF A NEW CATHETER WAS NECESSARY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378792 MALLINCKRODT LASER-FLEX TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention