BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTOTUBE

    MDR report key: 1359010 · Received April 8, 2009

    Report

    Report Number
    MW5010697
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 24, 2009
    Report Date
    April 8, 2009
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ASTOTUBE BLOOD WARMER TUBING SET HAD NO LOT NUMBER, REF. # MOD #, MANUFACTURE DATE, OR EXPIRY DATE PRINTED ON THE PACKAGE. THIS DEFECTIVE PACKAGE WAS CONTAINED IN A BOX LABELED LOT # 32244758. THE MOD# 77460001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASTOTUBE BLOOD WARMER TUBING LGZ STIHLER ELECTRONIC GMBH 77460001 33244758

    Patients

    Seq Age Sex Outcome Treatment
    1