BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® SPINAL ANESTHESIA TRAYS

    MDR report key: 5579090 · Received April 14, 2016

    Report

    Report Number
    2183502-2016-00791
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    February 25, 2016
    Report Date
    April 14, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    CAZ
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTICE THE CHANGES MADE BY MANUFACTURER: DATE OF REPORT WAS UPDATED TO TODAY'S DATE (04/14//2016). COMMENT ADDED, "THE FIRST INCIDENT WAS CAPTURED UNDER THE MANUFACTURER'S REFERENCE NUMBER: 2183502-2016-00791. THE SECOND INCIDENT REFERRED TO ABOVE IS BEING CAPTURED ON THE MANUFACTURER'S REFERENCE NUMBER: 2183502-2016-00792." THE USER FACILITY REPORTED 2 EVENTS ON 1 MEDWATCH. THE MANUFACTURER HAS FILED 2 SEPARATE REPORTS TO CAPTURE BOTH EVENTS. 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    TWO INCIDENTS .... 1 SPINAL GIVEN IN OR FOR PREGNANT PT. FOR CYSTOSCOPY. SAB PLACED W/O ANY ISSUES. WAITED 15MIN AND PT HAD NO EFFECT FROM SA'B. HAD TO CONVERT TO GENERAL ANESTHETIC. (B)(6). 97614762 1 SPINAL GIVEN FOR POST PARTUM TUBAL. SAB TOOK CLOSE TO 12 MIN TO "SET UP." SURGEON STILL HAD TO INJECT LOCAL IN ORDER KEEP PT COMFORTABLE. REF # (B)(4), LOT 3115757; REF# (B)(4), LOT 3093098. THE FIRST INCIDENT WAS CAPTURED UNDER THE MANUFACTURER'S REFERENCE NUMBER: 2183502-2016-00791. THE SECOND INCIDENT REFERRED TO ABOVE IS BEING CAPTURED ON THE MANUFACTURER'S REFERENCE NUMBER: 2183502-2016-00792.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231700 PORTEX® SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL ASD INC., NA 3115757

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR