BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLE

    MDR report key: 10715154 · Received October 21, 2020

    Report

    Report Number
    9616656-2020-01042
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 6, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 6 NOVEMBER 2020 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD ULTRA FINE¿ PEN NEEDLES CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONSUMER STATED SHE OPENED A NEW BOX MAT#320122 WITH LOT# 0022823 AND HAD 8 MORE NEEDLES THAT CLOGGED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 BD ULTRA FINE¿ PEN NEEDLES CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CONSUMER STATED SHE OPENED A NEW BOX MAT# 320122 WITH LOT# 0022823 AND HAD 8 MORE NEEDLES THAT CLOGGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180409 BD ULTRA FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 0022823 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1