BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY PVC - PORTEX TUBES BLUE

    MDR report key: 15598994 · Received October 13, 2022

    Report

    Report Number
    3012307300-2022-23882
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    July 3, 2018
    Report Date
    October 13, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    PMA / PMN Number
    K173384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI IS UNKNOWN. NO INFORMATION PROVIDED TO DATE. THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A SAMPLE WAS RECEIVED. AS A RESULT OF CHECKING THE ACTUAL PRODUCT, THE PRODUCT NUMBER / LOT OF THE BLISTER PACK AND THE COSMETIC BOX AND THE PRODUCT NUMBER / LOT COINCIDED WITH EACH OTHER. THE ORIGINAL LABEL OF BLISTER PACK AND JAPANESE LABELS ALL MATCH. FROM THIS FACT, IT WAS CONFIRMED THAT THERE WAS NO ERROR UNTIL DELIVERY. THE REPORTED EVENT WAS CONFIRMED. HOWEVER, THERE IS A HIGH POSSIBILITY THAT IT OCCURRED AFTER SHIPMENT. THIS EVENT WILL BE MONITORED AND THE OCCURRENCE FOR TRENDING PURPOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CUSTOMER CHECKED THE STOCKED PRODUCTS, THEY NOTICED A 100/860/080 WAS PACKED IN A 100/800/080'S OUTER BOX. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272947 TRACHEOSTOMY PVC - PORTEX TUBES BLUE TUBE, TRACHEOSTOMY BTO SMITHS MEDICAL ASD, INC. 3578815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown