BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TT (TRACHEOSTOMY TUBES)

    MDR report key: 6974453 · Received October 24, 2017

    Report

    Report Number
    9611710-2017-00036
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 21, 2017
    Product Code
    BTR
    PMA / PMN Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: TUBE, TRACHEAL (W/WO CONNECTOR). PRODUCT CODE: BTR. PMA/510K: K951696. INITIAL REPORTER: COMPLAINANT STREET ADDRESS IS (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NONE HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LAST THREE PMR'S FOR TRENDS INDICATED NO TRENDS FOR THIS ISSUE ON THIS PRODUCT. HISTORICAL COMPLAINT DATA FROM (B)(6) 2015 TO (B)(6) 2017 WAS REVIEWED AS IT RELATES TO THE REPORTED EVENT. A TOTAL OF 1 COMPLAINT, INCLUDING THIS ONE, WAS REPORTED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE CUFF LEAKAGE WAS NOTED DURING PRETESTING OF THE DEVICE. THE DEVICE WAS NOT USED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION OR PHOTOGRAPH WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750328 TT (TRACHEOSTOMY TUBES) BTR MM62525075 542689R002

    Patients

    Seq Age Sex Outcome Treatment
    1