BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFED BD PEN NEEDLE

    MDR report key: 9175919 · Received October 10, 2019

    Report

    Report Number
    9616656-2019-00976
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 26, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE REPORTED LOT# 9022892 WAS PROVIDED; HOWEVER, THE CATALOG NUMBER WAS NOT PROVIDED. THE CATALOG IS UNKNOWN AS THE BD MANUFACTURING PORTAL PROVIDES MULTIPLE CATALOG NUMBERS FOR THIS LOT NUMBER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND 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. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9022892. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE CLOG OCCURRED WITH A UNSPECIFIED BD PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NO INSULIN FLOW WHEN PRIMING. ALWAYS PRIMES BEFORE USE. ABOUT HALF A DOZEN PEN NEEDLES AFFECTED FROM THE BOX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968356 UNSPECIFED BD PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other