BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6175489 · Received December 15, 2016

    Report

    Report Number
    9616656-2016-00080
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 1, 2016
    Report Date
    January 31, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5230047. CONCLUSIONS - AS THERE WAS NO ACTUAL SAMPLE RETURNED FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RECEIVED A NEEDLE STICK WHEN RE-SHIELDING THE INNER SHIELD OF THE SUSPECT DEVICE. THE CUSTOMER APPLIED OTC POLYSPORIN. SHE SHOWED THE SITE TO THE NURSE WHEN SHE WAS AT THE DOCTOR FOR A CHECK UP, BUT DID NOT RECEIVED MEDICAL TREATMENT "FOR SMALL INFECTION AND RED MARK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826123 BD ULTRA-FINE¿ PEN NEEDLE 32G X 4MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5230047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other