BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS TRACHEOSTOMY TUBES ADD TO INQUIRY ADD TO BROCHURE

    MDR report key: 5516148 · Received March 22, 2016

    Report

    Report Number
    2183502-2016-00564
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    November 29, 2015
    Report Date
    March 22, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. (B)(4). THE DEVICE EVALUATION IS NOT COMPLETE, BUT IS UNDERWAY. INVESTIGATION ONGOING.

    Additional Manufacturer Narrative · 1

    ONE USED AND TWO UNUSED PORTEX® BIVONA® ADULT TTS TRACHEOSTOMY TUBES WERE RETURNED FOR EVALUATION. IT COULD NOT BE DETERMINED WHICH DEVICE WAS ASSOCIATED WITH THE REPORTED EVENT; THEREFORE, THE EVALUATION OF ALL RETURNED DEVICES WILL BE USED FOR THE MEDWATCH. VISUAL INSPECTION OF THE USED DEVICE FOUND THAT IT HAD A DEFORMED PLASTIC CONNECTOR. VISUAL INSPECTION OF THE FIRST UNOPENED DEVICE FOUND THAT IT HAD A DEFORMED CONNECTOR. VISUAL INSPECTION OF THE SECOND UNOPENED DEVICE DID NOT HAVE A DEFORMED CONNECTOR. THE CONNECTOR ON ALL RETURNED DEVICES WAS INSPECTED AND DETERMINED TO NOT MATCH THE MANUFACTURING SPECIFICATIONS. A REVIEW OF THE MATERIAL, SUPPLIER, MOLDING, ASSEMBLY, ENVIRONMENT, AND EXTERNAL SOURCES WAS UNABLE TO IDENTIFY A ROOT CAUSE. (B)(4). MFR# CLARIFICATION: NEW REGISTRATION NUMBER 3012307300. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE DEVICE USER THAT A NURSE WAS PLACING A TRACHEOSTOMY TUBE, WHEN SHE NOTICED THE 15MM CONNECTOR WAS LARGER THAN NORMAL. ACCORDING TO THE REPORTER, THE CONNECTOR WAS THICK AND MADE IT DIFFICULT TO CONNECT AND DISCONNECT FROM THE VENTILATOR TUBING. THIS ISSUE WAS DISCOVERED UPON DEVICE PLACEMENT. THE REPORTER INDICATED THAT NO ADVERSE EFFECTS RESULTED FROM EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174610 PORTEX® BIVONA® ADULT TTS TRACHEOSTOMY TUBES ADD TO INQUIRY ADD TO BROCHURE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA 3069499

    Patients

    Seq Age Sex Outcome Treatment
    1