BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8400206 · Received March 7, 2019

    Report

    Report Number
    9616656-2019-00216
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 8, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903296057
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) OPEN 5MM, 30G BD AUTOSHIELD DUO SAMPLES FROM LOT # 8081867. CUSTOMER STATES THAT DURING THE APPLICATION OF INSULIN, WITH THE CORRECT TECHNIQUE, AFTER 10 SEC. PRESENTED EXTRAVASATION OF INSULIN IN OSTIUM. THE RETURNED PEN NEEDLE WAS RETURNED NOT ACTIVATED. THE SAMPLE WAS TESTED AND WAS ABLE TO EXPEL PROPERLY AND ACTIVATE PROPERLY WITHOUT ANY OBSERVED DEFECTS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE DURING APPLICATION OF INSULIN THERE WAS EXTRAVASATION OF INSULIN IN OSTIUM. THE REPORT IS AS FOLLOWS, "DURING THE APPLICATION OF INSULIN, WITH THE CORRECT TECHNIQUE, AFTER 10 SEC. PRESENTED EXTRAVASATION OF INSULIN IN OSTIUM."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING A BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE DURING APPLICATION OF INSULIN THERE WAS EXTRAVASATION OF INSULIN IN OSTIUM. THE REPORT IS AS FOLLOWS, "DURING THE APPLICATION OF INSULIN, WITH THE CORRECT TECHNIQUE, AFTER 10 SEC. PRESENTED EXTRAVASATION OF INSULIN IN OSTIUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195624 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8081867 00382903296057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other