BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM

    MDR report key: 8155745 · Received December 12, 2018

    Report

    Report Number
    3006948883-2018-00321
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DHR OF LOT 8030477 WAS REVIEWED AND NO QN FOUND; MANUFACTURE RECORDS (B)(4) WERE REVIEWED, NO ABNORMAL WAS FOUND; 14PCS OF RETAIN SAMPLES HAVE BEEN TESTED ON THREAD FUNCTION AND CLOG TEST, ALL RESULTS MEET THE SPECIFICATION. BASED ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE 31GX5MM WAS CLOGGED DURING USE.

    Additional Manufacturer Narrative · 1

    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 A PEN NEEDLE 31GX5MM WAS CLOGGED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997564 PEN NEEDLE 31GX5MM PEN NEEDLE FMI BD (SUZHOU) 8030477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other