BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT-LET AUTO CLINICAL SAFETY LANCET

    MDR report key: 2651317 · Received February 24, 2009

    Report

    Report Number
    1058955-2009-00002
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    November 22, 2007
    Report Date
    February 23, 2009
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO REMEDIAL ACTION WAS TAKEN AS A RESULT OF THIS REPORTING. DUE TO OTHER ISSUES STAT MEDICAL WAS NO LONGER PURCHASING PRODUCT FROM THE CONTRACT MANUFACTURER (B)(4). WE TERMINATED OUR RELATIONSHIP WITH (B)(4) IN JANUARY 2007 AND HAD MOVED THE MANUFACTURE OF THE STAT-LET AUTO CLINICAL SAFETY LANCET TO ANOTHER MANUFACTURER WHERE THERE WAS GREATER CONTROL OF THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AFTER FIRING A STAT-LET AUTO SAFETY LANCET TO OBTAIN BLOOD FROM A PATIENT, A NURSE IN THE HOSPITAL IN (B)(6) NOTICED THAT THE LANCET FAILED TO RETRACT BACK INTO THE BODY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT-LET AUTO CLINICAL SAFETY LANCET STAT-LET AUTO, LANCET FMK STAT MEDICAL DEVICES, INC. SAP NMSM-12-05-1

    Patients

    Seq Age Sex Outcome Treatment
    1