BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR-CRIT PLASTIC CAPILLARY TUBES

    MDR report key: 247147 · Received October 28, 1999

    Report

    Report Number
    MW1017436
    Event Type
    Malfunction
    Date Received
    October 28, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 28, 1999
    Manufacturer
    SEPARATION TECHNOLOGY, INC.
    Product Code
    GIO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A FINGERSTICK PUNCTURE WAS PERFORMED ON A POTENTIAL BLOOD DONOR. A SAMPLE OF BLOOD WAS TO BE OBTAINED TO DETERMINE THE DONOR'S HEMATOCRIT. THE CAPILLARY TUBES DID NOT APPEAR TO FILL WITH BLOOD IN A ROUTINE MANNER. THE HEMATOCRIT VALUE OBTAINED FOR THE DONOR WAS ONLY 24%. FURTHER INVESTIGATION REVEALED THAT THE INSIDE DIAMETER(ID) OF THE CAPILLARY TUBES IN THE SLEEVES(VIALS) WAS ONLY 0.5MM INSTEAD OF 1.1MM. THE VIALS WERE LABELED AS CONTAINING 1.1MM(ID) TUBES. ANOTHER HEMATOCRIT DETERMINATION WAS PERFORMED ON THE DONOR WITH 1.1MM(ID) TUBES AND THE RESULT OBTAINED WAS 37% AS COMPARED TO THE PREVIOUS RESULT OF 24%. RPTR RETRIEVED 8 BOXES OF CAPILLARY TUBES(200 TUBES/VIAL) AND EACH BOX HAD 1 VIAL OF TUBES, 0.5MM(ID) AND THE VIAL WAS LABELED AS CONTAINING 1.1MM(ID) TUBES. ALL OTHER VIALS CONTAINED TUBES 1.1(ID) IN APPROPRIATELY LABELED VIALS. THE MFR WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR-CRIT PLASTIC CAPILLARY TUBES CAPILLARY TUBES GIO SEPARATION TECHNOLOGY, INC. NA 11208-06079-1239

    Patients

    Seq Age Sex Outcome Treatment
    1 *