BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX SPINAL ANESTHESIA TRAYS

    MDR report key: 4862595 · Received June 19, 2015

    Report

    Report Number
    2183502-2015-00430
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    January 21, 2015
    Report Date
    June 18, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE SUPPLIER OF THE ANAESTHESIA MEDICATION COMPLETED A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT AND CONCLUDED THAT THE PRODUCT MET WITH SPECIFICATIONS AT FINAL TESTING. THE SUPPLIER ALSO TESTED RETAINED SAMPLES FROM THE SAME LOT FOR POTENCY. ALL TESTING FOUND THE PRODUCT TO MEET WITH SPECIFICATIONS.

    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 STATING THAT A PATIENT WAS PLANNED TO HAVE A CAESAREAN SECTION WHEN THE LISTED DEVICE WAS USED TO ADMINISTER A LOCAL ANESTHESIA. THE PATIENT REPORTEDLY RECEIVED INSUFFICIENT LOCAL ANESTHESIA; THEREFORE, THE PATIENT WAS GIVEN GENERAL ANESTHESIA. NO ADVERSE EFFECTS TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400225 PORTEX SPINAL ANESTHESIA TRAYS CAZ SMITHS MEDICAL ASD, INC. NA 2870116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other