BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8772716 · Received July 9, 2019

    Report

    Report Number
    9616657-2019-00252
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 20, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD ULTRA FINE¿ PEN NEEDLES CLOGGED DURING USE AND WERE DIFFICULT TO OPERATE DUE TO IMPROPER PLACEMENT ON THE PEN. THE CONSUMER REPORTEDLY REUSED PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM # 320122 LOT 8242847 FINDING EVERY 2-3 PEN NEEDLE CLOG CHANGES THE PEN NEEDLE UNTIL FINDS ONE THAT WORKS. CONSUMER JUST STARTED USING PEN NEEDLES 30 DAYS AGO. WASTED 20 PEN NEEDLES SO FAR. CONSUMER IS REUSING. INFORMED NOT TO REUSE AND PROPER PLACEMENT TO TRESEIBA PEN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 20 BD ULTRA FINE¿ PEN NEEDLES CLOGGED DURING USE AND WERE DIFFICULT TO OPERATE DUE TO IMPROPER PLACEMENT ON THE PEN. THE CONSUMER REPORTEDLY REUSED PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ITEM # 320122 LOT 8242847 FINDING EVERY 2-3 PEN NEEDLE CLOG CHANGES THE PEN NEEDLE UNTIL FINDS ONE THAT WORKS. CONSUMER JUST STARTED USING PEN NEEDLES 30 DAYS AGO. WASTED 20 PEN NEEDLES SO FAR. CONSUMER IS REUSING. INFORMED NOT TO REUSE AND PROPER PLACEMENT TO TRESEIBA PEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564640 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 8242847 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other