BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

    MDR report key: 6667521 · Received June 26, 2017

    Report

    Report Number
    3012307300-2017-01364
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    February 26, 2017
    Report Date
    June 26, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CATALOG NUMBER OF THE AFFECTED DEVICE WAS 100/523/070, HOWEVER, THE REPORTED LOT NUMBER OF 3178621 CORRESPONDS WITH THE CATALOG NUMBER OF 100/523/080. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PRODUCT WAS IN USE, THE "FIXING HOLE" OF A PORTEX® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE WAS BROKEN AND "THE PRODUCT COULD NOT BE FIXED". NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448616 PORTEX® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 3178621

    Patients

    Seq Age Sex Outcome Treatment
    1