BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBC SPRINGTEN 0.25X30

    MDR report key: 1217529 · Received October 30, 2008

    Report

    Report Number
    MW5008835
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 30, 2008
    Product Code
    MQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS FOLLOW UP TO FILED IN 2008, NEW ACUPUNCTURE NEEDLES FROM DIFFERENT MFR WERE ORDERED TO REPLACE THE PREVIOUSLY REPORTED FAULTY PACKAGES. ON THE FOLLOWING MONTH, WE DISCOVERED A SIMILAR PROBLEM WITH FIVE PACKAGES OF DBC SPRINGTEN 0.25X30, EXPIRATION DATE 2011-06 SINGE USE ACUPUNCTURE NEEDLES. THESE ARE PACKAGES THAT CONTAIN MULTIPLE (10) LOOSE NEEDLES PLUS A GUIDE TUBE IN STERILE PACKAGING. IT APPEARS THAT THROUGH SHIPPING AND HANDLING, IN SOME INSTANCES, THE TIPS OF THE NEEDLES HAVE PENETRATED THE PLASTIC SHEATH AND PROTRUDE FROM THE PACKAGE COMPROMISING BOTH STERILITY AND CREATING A NEEDLE STICK HAZARD. WE TOOK DIGITAL PICTURES OF THE PACKAGING, CONTACTED OUR SUPPLIER AND PROVIDED THEM WITH COPIES OF THE PHOTOS. BOTH THIS SUPPLIER AND THE PREVIOUS SUPPLIER HAVE INDICATED CORRESPONDENCE WITH THE MFR'S AND THAT STEPS WERE BEING TAKEN TO CORRECT THE PACKAGING. WE HAVE REQUESTED WRITTEN DOCUMENTATION, BUT HAVE NOT YET RECEIVED ANY. PLEASE NOTE THAT THIS WAS DISCOVERED DURING THE NORMAL COURSE OF BUSINESS AND WAS NOT AS A RESULT OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DBC SPRINGTEN 0.25X30 ACUPUNTURE NEEDLES MQX

    Patients

    Seq Age Sex Outcome Treatment
    1 *