BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS

    MDR report key: 2870144 · Received December 3, 2012

    Report

    Report Number
    2183502-2012-00577
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    CAZ
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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

    A REPORT WAS RECEIVED THAT STATED THAT A PATIENT RECEIVED INSUFFICIENT LOCAL ANESTHESIA WHEN THE SUSPECT MEDICAL DEVICE WAS USED. IT WAS NECESSARY TO PLACE THE PATIENT UNDER GENERAL ANESTHESIA DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS CAZ - ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC NA 2258634

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention