BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD PEN NEEDLE

    MDR report key: 1844750 · Received September 21, 2010

    Report

    Report Number
    9610847-2010-00041
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BD MEDICAL - INFUSION THERAPY SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K060007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN MANUFACTURING INVESTIGATION BECOMES AVAILABLE. EVALUATION SUMMARY: ISSUE: INJURY NEEDLE STICK. REGULATORY COMPLIANCE RECEIVED ONE (1) USED 29G X 8MM AUTOSHIELD PEN NEEDLE WITH NO OUTER COVER WHICH CUSTOMER CLAIMS: AFTER USE, THE NURSE WAS REMOVING THE AUTOSHIELD NEEDLE FROM THE INSULIN PEN AND WAS PUNCTURED BY AN EXPOSED NEEDLE. THE RETURNED PRODUCT WAS EVALUATED AND THE FOLLOWING WAS OBSERVED DURING EXAMINATION: ONLY ONE METAL TAB WAS ENGAGED, HOWEVER, IT WAS NOT PROPERLY ENGAGED. THE OTHER TWO METAL TABS WERE NOT ENGAGED. EXPOSED CANNULA WAS ALSO OBSERVED. CONFIRMED DEFECT. PRODUCT FORWARDED TO MANUFACTURING FOR FURTHER INVESTIGATION. UNABLE TO PERFORM COMPLAINT HISTORY CHECK; LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE NURSE WAS REMOVING THE AUTOSHIELD NEEDLE FROM THE INSULIN PEN AFTER USE AND WAS PUNCTURED BY AN EXPOSED NEEDLE. INJURY REPORT HAS BEEN FILED WITH EMPLOYEE HEALTH AND BLOODBORNE EXPOSURE PROTOCOL IS BEING FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD AUTOSHIELD PEN NEEDLE 29 GA X 8MM PEN NEEDLE FMI BD MEDICAL - INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other