BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD (COMPLETE KIT)/HOSPIRA (MEDICATION WITHIN THE KIT)

    MDR report key: 1032995 · Received April 21, 2008

    Report

    Report Number
    MW5006357
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    December 31, 2007
    Report Date
    April 18, 2008
    Manufacturer
    BD MEDICAL
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPINAL ANESTHESIA KIT FAILED. NO INJURY OR ADVERSE EFFECT TO PT. OCCURRED THREE TIMES OVER A THREE MONTH PERIOD. PRODUCT WAS RETURNED TO MFR AND REPLACED WITH THE SAME TYPE OF KIT. NO FAILURES SINCE THE THREE INCIDENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD (COMPLETE KIT)/HOSPIRA (MEDICATION WITHIN THE KIT) SPINAL ANESTHESIA KIT CAZ BD MEDICAL NA 45060DD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other BD GD843813| MARCAINE