BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPOCAN

    MDR report key: 2081932 · Received May 2, 2011

    Report

    Report Number
    2081932
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    WORKER IN DISTRIBUTION CENTER NOTICED A HAIR INSIDE OF THE "STERILE PACKAGE" OF A COMBINED SPINAL / EPIDURAL ANESTHESIA SET. INDIVIDUAL UNIT WAS QUARANTINED AND REMOVED FROM DISTRIBUTION; WORKER BROUGHT THIS ITEM TO MANAGER.SYSTEMATIC REVIEW OF OTHER UNITS OF THE SAME ITEM NUMBER REVEALED NO OTHER UNITS WITH SIMILAR SUBSTANCES PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPOCAN COMBINED SPINAL / EPIDURAL PRODUCT CAZ B. BRAUN MEDICAL INC * 60871231

    Patients

    Seq Age Sex Outcome Treatment
    1 *