BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    MDR report key: 6522742 · Received April 26, 2017

    Report

    Report Number
    3012307300-2017-00893
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 26, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15021312005752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 AND PEDIATRIC TRACHEOSTOMY TUBE LEFT EYELET TORE THREE-QUARTERS OF THE WAY DURING USE ON A PATIENT. THE ISSUE WAS OBSERVED BY THE PATIENT'S PARENT WHEN SHE AWOKE FROM A NAP. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR 2 WEEKS. IT WAS NOTED THAT DALE TRACHEOSTOMY TUBE TIES HAD BEEN USED TO HOLD THE TUBE IN PLACE. THE TUBE WAS DISCARDED AND REPLACED WITH A NEW TRACHEOSTOMY TUBE. NO PATIENT INJURY WAS REPORTED. THE ISSUE WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303028 PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 15021312005752

    Patients

    Seq Age Sex Outcome Treatment
    1 30 MO