BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL 22G WHITACRE FORTEX

    MDR report key: 5513429 · Received March 17, 2016

    Report

    Report Number
    MW5060963
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    TWO INCIDENTS. ONE SPINAL GIVEN IN OPERATING ROOM FOR PREGNANT PT FOR CYSTOSCOPY. SAB PLACED W/O ANY ISSUES. WAITED 15 MINUTES AND PT HAD NO EFFECT FROM SAB. HAD TO CONVERT TO GENERAL ANESTHETIC. (B)(6), 1 SPINAL GIVEN FOR POST PARTUM TUBAL. SAB TOOK CLOSE TO 12 MIN TO "SET UP." SURGEON STILL HAD TO INJECT LOCAL IN ORDER TO KEEP PT COMFORTABLE. REF # NLD 15545C-21, LOT 3115757 REF # NLD 15545C-21, LOT 3093098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163939 SPINAL 22G WHITACRE FORTEX SPINAL INTRATHECAL CAZ SMITHS MEDICAL ASD INC. NLD-15545C-21 3115757
    163940 SPINAL 22G WHITACRE FORTEX SPINAL INTRATHECAL CAZ SMITHS MEDICAL ASD INC. NLD-15545C-21 3093098

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR