BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

    MDR report key: 7474076 · Received April 30, 2018

    Report

    Report Number
    3012307300-2018-01326
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    January 1, 2017
    Report Date
    July 11, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312014747
    PMA / PMN Number
    K944178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE RECEIVED CONNECTED TO AN UNKNOWN PRODUCT. THE SAMPLES WERE IN USED CONDITION WITHOUT THEIR ORIGINAL PACKAGING. VISUAL INSPECTION NOTED THE 15 MILLIMETER CONNECTORS WERE ATTACHED TO THE UNKNOWN PRODUCT. FUNCTIONAL TESTING INCLUDED USE TESTING. AN ATTEMPT WAS MADE TO SEPARATE THE CONNECTOR FROM THE UNKNOWN PRODUCT AND IT WAS VERY EASY TO SEPARATE THE CONNECTORS WITH BOTH SAMPLES. ADDITIONAL SAMPLES WERE CONNECTED AGAIN TO THE UNKNOWN PRODUCT AND THEY WERE SEPARATED USING A DISCONNECTING WEDGE, ONCE THE WEDGE WAS INSERTED, THE CONNECTORS WERE SEPARATED EASILY WITHOUT APPLYING ANY FORCE. THE DIAMETER OF THE CONNECTORS WERE INSPECTED AND NO DISCREPANCIES WERE FOUND. BASED ON THE EVIDENCE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K): K083641.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIRWAY ADAPTER COULD NOT BE SEPARATED FROM THE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT. THE PATIENT WAS HOWEVER MANUALLY "BAGGED" WHILE THE AIRWAY ADAPTER WAS REMOVED FROM THE TRACHEOSTOMY TUBE ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316183 PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3332238 15021312014747

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE PHILIPS M2772A AND M2773A ADAPTERS