BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET

    MDR report key: 1024293 · Received April 2, 2008

    Report

    Report Number
    1723684-2008-00001
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 13, 2008
    Report Date
    April 1, 2008
    Manufacturer
    SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR DEVICES (LOT AND CATALOG NUMBERS UNKNOWN) WERE THE SUBJECT OF COMPLAINTS. THE MALFUNCTION WAS AN INCOMPLETE SAFETY MECHANISM LOCKOUT. ADHESIVE ON NEEDLE/SLEEVE WAS CONFIRMED. CUSTOMER SUGGESTS POTENTIAL LOTS INVOLVED MAY BE D727604, D722118, D717031 AND D717033. ALL WERE MANUFACTURED PRIOR TO NOV. 16, 2007 - THE DATE AT WHICH IMPROVEMENTS WERE MADE TO MITIGATE THIS OCCURRENCE. THERE WAS NO INJURY OF ANY SORT.

    Description of Event or Problem · 1

    SAFETY HUBER ADMINISTRATION SET WAS NOT ABLE TO LOCK OUT. THERE WAS NO INJURY OF ANY SORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP HUBER NEEDLE SET SAFETY ADMINISTRATION SET FPA SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC. SAFESTEP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other