BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TRACHEOSTOMY

    MDR report key: 15437196 · Received September 16, 2022

    Report

    Report Number
    3012307300-2022-19425
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Report Date
    September 16, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312516791
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THREE (3) SAMPLES WERE RECEIVED FROM P/N 60PFSS45 L/N 3991195 IN UNUSED CONDITIONS INSIDE THEIR CLOSED ORIGINAL PACKAGING. IN ADDITION, ONE PHOTO WAS RECEIVED AND IT WAS OBSERVED THAT PRODUCTS INSIDE THE TRAYS DON'T MATCH LABELING, LABELING IS FOR A PRODUCT WITH A STRAIGHT FLANGE AND THE PRODUCT INSIDE THE TRAY HAS A ?V" FLANGE. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED FROM VISUAL INSPECTION OF THE PHOTO AND SAMPLES RECEIVED. A DEVICE HISTORY REVIEW WAS PERFORMED AND IT WAS FOUND THAT THE REPORTED PART AND LOT NUMBER WAS ASSEMBLED CORRECTLY ACCORDING TO ITS BILL OF MATERIALS AND LABELING. THE REPORTED ISSUE IS A KNOWN ISSUE AND A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE CONFIRMED FAILURE. D5 AND E4 IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE LABEL LISTS A STRAIGHT FLANGE BUT THE TRACH RECEIVED HAD A V-FLANGE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466235 BIVONA TRACHEOSTOMY NEONATAL/PEDIATRIC TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 60PFSS45 3991195 15021312516791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown