BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSULIN PEN NEEDLE

    MDR report key: 5210726 · Received November 9, 2015

    Report

    Report Number
    9616656-2015-00017
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 28, 2015
    Report Date
    November 6, 2015
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: WITHOUT KNOWING THE SPECIFIC DEVICE MODEL AND ITS ASSOCIATED CAT. AND LOT. NUMBERS, THE 510(K) # IS UNKNOWN. THE FIVE POSSIBLE 510(K) NUMBERS FOR BD INSULIN PEN NEEDLES ARE; K110703, K110105, K100005, K060007. AND K051899. RESULTS: A SAMPLE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSUMER CAME INTO THE (B)(6) WITH A USED BD INSULIN PEN NEEDLE (UNKNOWN MODEL) WITH ONLY THE INNER SHIELD COVERING THE NEEDLE. THE CONSUMER COMPLAINED THAT THE PEN NEEDLE WAS CLOGGED AND HANDED IT TO A PHARMACIST. THE PHARMACIST REMOVED THE INNER SHIELD TO INVESTIGATE THE CONSUMER'S CLAIM AND THEN RE-SHIELDED THE PEN NEEDLE. WHEN HE RE-SHIELDED THE NEEDLE, THE NEEDLE WENT THOUGH THE INNER SHIELD AND STUCK HIS FINGER. THE PHARMACIST THEN WENT TO A WORKER'S COMP DOCTOR WHERE THEY DREW BLOOD AND GAVE HIM A TETANUS SHOT. THE PHARMACIST RETURNED TO THE DOCTOR ONE WEEK LATER AND WAS TOLD THE TEST RESULTS WERE NEGATIVE. HE WAS OFFERED A 28 DAY COURSE OF PROPHYLACTIC MEDICATION BUT OPTED NOT TO TAKE IT. THE PHARMACIST WILL BE RE-EVALUATED AND HAVE ADDITIONAL LAB WORK DONE EVERY SIX WEEKS OVER A SIX MONTH TIMEFRAME. THE PHARMACIST ALSO REPORTED THAT HE IS FEELING FINE AND HAS NOT HAD ANY OTHER MEDICAL INTERVENTIONS RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740459 BD INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention