BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31 G X 8 MM BD¿ ULTRA FINE¿ SHORT INSULIN PEN NEEDLE

    MDR report key: 6074889 · Received November 3, 2016

    Report

    Report Number
    9616656-2016-00070
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 15, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR EVALUATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THE REPORTED LOT 6061834, 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.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER GAVE HER MOM AN INJECTION WITH THE SUSPECT DEVICE AND REPLACED THE INNER SHIELD. THE NEEDLE WENT THROUGH THE SHIELD AND STUCK HER THUMB. ALTHOUGH THE SITE HURTS, NO MEDICAL INTERVENTIONS WERE SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728334 31 G X 8 MM BD¿ ULTRA FINE¿ SHORT INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6061834

    Patients

    Seq Age Sex Outcome Treatment
    1 Other