BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® SPINAL ANESTHESIA TRAYS

    MDR report key: 7550684 · Received May 29, 2018

    Report

    Report Number
    3012307300-2018-10199
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    August 22, 2016
    Report Date
    May 29, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PLACING THE SAB WITH STANDARD TECHNIQUE, ABOUT 25 MINUTES ELAPSED FROM THE BLOCK TO THE SURGICAL PROCEDURE. WHEN THE INCISION WAS MADE, IT WAS APPARENT THAT PATIENT WAS FEELING PAIN. THIS HAPPENED ON TWO DIFFERENT PATIENTS. ON BOTH OCCASIONS, THE CLINICIAN HAD TO CONVERT TO GENERAL ANESTHESIA IN ORDER TO CONTINUE WITH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391593 PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1