BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ INSULIN PEN NEEDLE, 32G X 4MM

    MDR report key: 6196378 · Received December 21, 2016

    Report

    Report Number
    9616656-2016-00084
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    December 5, 2016
    Report Date
    January 10, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6096588. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PATIENT WITH A KNOWN NICKEL ALLERGY HAD USED A BD ULTRA-FINE INSULIN PEN NEEDLE, 32 G X 4 MM TO INJECT INSULIN, HE DEVELOPED LARGE RED WELTS AND BRUISES THAT LOOKED LIKE CELLULITIS. THE PATIENT WAS PRESCRIBED A PROPHYLACTIC TOPICAL ANTIBIOTIC TO TREAT THIS. WITHIN 24-48 HOURS THE REDNESS DECREASED. THE PATIENT ALSO CHANGED THE TYPE OF NEEDLES HE WAS USING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845527 BD ULTRA-FINE¿ INSULIN PEN NEEDLE, 32G X 4MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6096588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention