BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAMPOLE ISOLATOR

    MDR report key: 582441 · Received March 9, 2005

    Report

    Report Number
    582441
    Event Type
    Malfunction
    Date Received
    March 9, 2005
    Date of Event
    February 1, 2005
    Report Date
    March 9, 2005
    Manufacturer
    WAMPOLE LABORATORIES
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LAB DID A MONTH-LONG STUDY ON BLOOD CULTURE COLLECTIONS, NOTING AMONG OTHER THINGS, CLOTTED TUBES. THE EXPERIENCED PHLEBOTOMISTS DID THEIR COLLECTIONS "BY THE BOOK", INCLUDING ROCKING AND SHAKING THE TUBES. ON EASY DRAWS THAT PRESENTED NO PROBLEMS THEY STILL ENDED UP WITH ABOUT 1/5 OF THE TUBES STILL BEING CLOTTED. IS THERE ENOUGH ANTI-COAGULANT IN THESE TUBES?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAMPOLE ISOLATOR BLOOD CULTURE COLLECTION TUBES JKA WAMPOLE LABORATORIES * 423812

    Patients

    Seq Age Sex Outcome Treatment
    1 *