BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTE8X NEONATAL/PEDIATRIC INTUBATION SYSTEM WITH STANDARD CONNECTOR

    MDR report key: 1920536 · Received December 6, 2010

    Report

    Report Number
    2183502-2010-00568
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    October 20, 2010
    Report Date
    December 3, 2010
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.,
    Product Code
    BTR
    PMA / PMN Number
    K790312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND 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

    USER FACILITY REPORTED THAT THE ENDOTRACHEAL TUBE SLIPPED THROUGH THE LOCK ON THE TUBE HOLDER. AS A RESULT, THE TUBE BECAME DISLODGED AND PATIENT WAS EXTUBATED. ACCORDING TO REPORTER, THE PATIENT BECAME BRADYCARDIAC AND REQUIRED RESUSCITATION AND RE-INTUBATION. NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTE8X NEONATAL/PEDIATRIC INTUBATION SYSTEM WITH STANDARD CONNECTOR BTR- ENDOTRACHEAL TUBE BTR SMITHS MEDICAL INTERNATIONAL LTD., NA 9474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention