BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES

    MDR report key: 6487515 · Received April 12, 2017

    Report

    Report Number
    3012307300-2017-00832
    Event Type
    Injury
    Date Received
    April 12, 2017
    Date of Event
    February 21, 2017
    Report Date
    April 12, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312000719
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY MEDWATCH FORM NUMBER: MW5068366. PM/510(K) NUMBER: K914088 AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS PLACED IN A PATIENT IN THE OPERATING ROOM AND DURING RESPIRATORY THERAPIST INITIAL ASSESSMENT, IT WAS OBSERVED THAT THE PACKAGING FOR THE TRACHEOSTOMY TUBE WAS LABELED AS NEONATAL, BUT THE DEVICE REFERENCE NUMBER AND LENGTH SPECIFICATIONS WERE CONSISTENT WITH A PEDIATRIC TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE DEVICE WAS MARKED AS 'PEDIATRIC' ON THE FLANGE. THE TUBE WAS CHANGED TO A NEONATAL TUBE. IT WAS UNCLEAR WHAT THE IMPACT TO THE PATIENT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267956 PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3272963 15021312000719

    Patients

    Seq Age Sex Outcome Treatment
    1 150 DA Other