BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6210871 · Received December 28, 2016

    Report

    Report Number
    3012307300-2016-00618
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K913859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 3150535 OR 3150536. POTENTIAL EXPIRATION DATE: 02/28/2021. POTENTIAL MANUFACTURING DATE: 02/28/2016. SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE 7.0MM ADULT TTS¿ TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE TWO POTENTIAL LOT NUMBER PROVIDED, FOUND THAT ALL IN-PROCESS AND FINAL INSPECTIONS WERE COMPLETED AND WERE IN SPECIFICATION. VISUAL INSPECTION WAS CONDUCTED WITH THE UNAIDED EYE AND UNDER NORMAL PLANT LIGHTING. ADDITIONALLY, THE DEVICE WAS MICROSCOPICALLY EXAMINED. DURING VISUAL INSPECTION, MULTIPLE AREAS OF DAMAGE WERE OBSERVED. ALSO, IT WAS NOTED THAT THE SUPERSLICK COATING WAS ABSENT FROM A 6MM BY 8MM SECTION ON THE ANTERIOR SIDE OF THE TRACHEOSTOMY TUBE SHAFT AND FROM A 10MM BY 15MM SECTION ON THE POSTERIOR SIDE OF THE TRACHEOSTOMY TUBE SHAFT. DURING FUNCTIONAL TESTING, THE DEVICE CUFF WAS INFLATED WITH AIR AND THEN THE DEVICE WAS SUBMERGED UNDER WATER. BUBBLES (INDICATING A LEAK) WAS OBSERVED ESCAPING FROM AN ABRADED AREA ON THE ANTERIOR SIDE OF THE CUFF. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUFF LEAK; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE CUFF WAS LEAKING AFTER HOURS OF USE. THE EVENT WAS OBSERVED IN A HOSPITAL BY HOSPITAL PERSONNEL SPONTANEOUSLY. THE CUFF PATENCY WAS TESTED PRIOR TO USE AND THE CUFF WAS FILLED WITH STERILE WATER. TWILL TIES PROVIDED WITH THE DEVICE WERE USED TO HOLD THE DEVICE IN PLACE. AN EMERGENT TRACHEOSTOMY TUBE CHANGED WAS REQUIRED DUE TO THE INCIDENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861122 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention