BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6083283 · Received November 7, 2016

    Report

    Report Number
    9616656-2016-00071
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE. DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR EVALUATION. A LOT HISTORY REVIEW WAS CARRIED OUT FOR THE REPORTED LOT 6061916. 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. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LARGE WELTS AND ITCHING AT THE INJECTION SITE WHILE USING THE SUSPECT DEVICE TO INJECT INSULIN WITH A NON-BD INSULIN PEN. THE WELTS HAVE OCCURRED DURING USE OF THE LAST 5 BOXES OF THE BD PEN NEEDLE. THE PATIENT IS NOT KNOWN TO HAVE ANY ALLERGIES AND ROTATES THE INJECTION SITE. THE TECHNIQUE WAS REVIEWED AND NO ISSUES WERE NOTED IN ADMINISTRATION. HE HAS SEEN MANY DOCTORS IN THE LAST 3 MONTHS AND HAS HAD ALLERGY TESTING. AT THE TIME OF REPORT THE CUSTOMER REPORTS THE DOCTORS "HAVE NOT HEARD OF THIS AND DO NOT KNOW WHAT TO DO". THE CUSTOMER REPORTS HE DOES NOT LEAVING THE NEEDLE IN THE SIGHT FOR 5-10 SECONDS AND IS EXPERIENCING LESS IRRITATION. HE USES AS AN OTC TOPICAL SPRAY FOR THE ITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734514 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6061916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention