BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6706925 · Received July 12, 2017

    Report

    Report Number
    3012307300-2017-01465
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) - K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE CONNECTOR ON THE RETURNED DEVICE DID NOT MATCH TO THE MANUFACTURING SPECIFICATION FOR OUTER DIAMETER AND TAPER. WHILE A 100 PERCENT ISO TAPER INSPECTION WAS IMPLEMENTED IMMEDIATELY PRIOR TO THE PACKAGING OF THE PRODUCT PRIOR TO RELEASE FOR DISTRIBUTION, NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED. TO RAISE AWARENESS AND LESSEN THE CHANCES OF ITS RECURRENCE, A QUALITY ALERT WAS POSTED TO ALL PERSONNEL INVOLVED WITH THIS PRODUCT'S MANUFACTURE. AS A PREVENTATIVE MEASURE, A NOTIFICATION WAS ALSO SENT TO THE SUPPLIER OF THIS COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PIECE WHERE YOU PLACE THE CONNECTOR" OF A PORTEX IVONA ADULT TTS TRACHEOSTOMY TUBE WAS TOO BIG, SO THE TWO PARTS DID NOT MATCH. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488094 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1