BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

    MDR report key: 6491307 · Received April 13, 2017

    Report

    Report Number
    3012307300-2017-00857
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 13, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15021312005714
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K912469 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® UNCUFFED NEONATAL TRACHEOSTOMY TUBE WAS INTUBATED IN THE PATIENT DURING AN OPERATION. AT 2:15AM ON THE NEXT DAY, AN ALARM ON THE ARTIFICIAL RESPIRATOR WAS HEARD AND IT WAS OBSERVED THAT THE TRACHEOSTOMY TUBE HAD COME OUT BY ACCIDENT. IT WAS UNKNOWN HOW THE TUBE WAS SECURED TO THE PATIENT. THE TUBE WAS CHECKED IN ACCORDANCE WITH ITS INSTRUCTIONS FOR USE PRIOR TO PLACEMENT. A RESUSCITATOR WAS USED TO AROUSE THE PATIENT. THE TIP OF THE TUBE WAS UNDER THE PATIENT'S SKIN AND AS A RESULT, A SUBCUTANEOUS EMPHYSEMA APPEARED AND CAUSED A PNEUMOTHORAX. THE PATIENT WENT INTO CARDIAC ARREST AND THE TRACHEOSTOMY TUBE WAS REMOVED WITH HASTE AND REPLACED WITH AN ENDOTRACHEAL TUBE, WHICH RESUSCITATED THE PATIENT. DUE TO THE INCIDENT, THE PATIENT WAS HYPOXIC FOR 23 MINUTES AND SUFFERED HYPOXIA-INDUCED ENCEPHALOPATHY AND EPILEPSY. THE EVENT WAS CONSIDERED ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271886 PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 3288134 15021312005714

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Life Threatening| S