BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 12657954 · Received October 19, 2021

    Report

    Report Number
    3012307300-2021-10085
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Report Date
    May 8, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312000375
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE UNITS WERE RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD NOT BE DUPLICATED. DHR REVIEW WAS DONE, NO ISSUES RELATED TO THE ORIGINAL COMPLAINT WERE FOUND., CORRECTED DATA: LOT NUMBER WERE CHANGED TO 3911420 AND 4056229.

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) , AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. DURING THE VISUAL INSPECTION, IT WAS OBSERVED ONE FLANGE WAS BROKEN. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE THE MOST PROBABLE ROOT CAUSE WAS THAT DAMAGED OCCURRED AFTER THE PRODUCT LEFT THE MANUFACTURING FACILITIES. NO ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLANGE BROKE LEADING TO A TRACH CHANGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555688 BIVONA TRACHEOSTOMY TUBE AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 60SP035 3911420 15021312000375

    Patients

    Seq Age Sex Outcome Treatment
    1 Male