BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE

    MDR report key: 8298224 · Received February 1, 2019

    Report

    Report Number
    3012307300-2019-00489
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    January 8, 2019
    Report Date
    April 2, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TRACHEOSTOMY AND THE CORRESPONDING BOX WAS RETURNED FOR EVALUATION. IT HAS BEEN CONFIRMED THAT THE ORIGINAL LABEL OF BLISTER PACK AND JAPANESE LABELS WERE VERIFIED. HOWEVER, THE ALLEGATION WAS DETERMINED TO HAVE OCCURRED BETWEEN THE SMITHS MEDICAL SITES OF TIJUANA AND KOMAKI.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT FOLLOWING THE INTUBATION OF A PATIENT WITH A SMITHS MEDICAL TRACHEOSTOMY, IT WAS NOTED TO BE A 100/800/080. THE PACKAGING HAD INDICATED 100/860/080. MEDICAL INTERVENTION WAS NOTED TO HAVE OCCURRED, HOWEVER NO ADVERSE EVENTS RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89560 PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3578815

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention