BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADD-A-NEEDLE SPINAL ANESTHESIA TRAY

    MDR report key: 989190 · Received January 16, 2008

    Report

    Report Number
    1722447-2008-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Report Date
    January 16, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRUG MANUFACTURER, HOSPIRA, WAS CONTACTED REGARDING THIS COMPLAINT. REP, HOSPIRA PRODUCT COMPLAINT ANALYST, STATED THAT THERE HAVE BEEN OTHER REPORTS ON THE LOT HOWEVER THEIR RETAINS HAVE TESTED WITHIN SPECIFICATION. SHE REQUESTED INFORMATION FROM THE REPORTER TO ALLOW HER TO REGISTER THE COMPLAINT AND CONTACT THE SOURCE. AFTER THE INFORMATION WAS PROVIDED, REP SAID SHE WOULD NEED 30 DAYS TO PROCESS THE COMPLAINT. THE DRUG AND MANUFACTURER INFORMATION IS AS FOLLOWS: MARCAINE HCL 0.75% W/DEXTROSE 8.25%, LIST 1761, LOT 42-205-DD. HOSPIRA, INC. NO EVIDENCE OF HANDLING OR ENVIRONMENTAL CONDITIONS EXISTS THAT WOULD COMPROMISE THE INTEGRITY OF THE DRUG.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE MARCAINE DRUG COMPONENT IN THE KIT IS NOT NUMBING THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN REQUESTED: MANUFACTURER OF THE DRUG. COMPONENT PRODUCT ID OF THE DRUG. LOT NUMBER OF THE INVOLVED UNITS. PROCEDURE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADD-A-NEEDLE SPINAL ANESTHESIA TRAY NONE CAZ HOSPIRA, INC. W0704119

    Patients

    Seq Age Sex Outcome Treatment
    1