BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAY

    MDR report key: 1844732 · Received September 21, 2010

    Report

    Report Number
    2183502-2010-00413
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 20, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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

    DURING A PROCEDURE THE 26G X 90MM PENCIL POINT NEEDLE BROKE. A 2.5CM FRAGMENT REMAINED IN SITU, THE CUSTOMER DECIDED TO LEAVE THE FRAGMENT IN PLACE. THE NO PERMANENT ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX SPINAL ANESTHESIA TRAY CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK