BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 7 PACK

    MDR report key: 8466362 · Received March 29, 2019

    Report

    Report Number
    3006948883-2019-00229
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 14, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS SAMPLE REVIEWED AND MANUFACTURE PROCESS ANALYSIS, THIS DEFECT WAS CAUSED BY MANUFACTURING PROCESS. DHR OF LOT 8030466 WAS REVIEWED AND NO ABNORMAL FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE PEN NEEDLE 31GX5MM 7 PACK IT WAS FOUND THAT HUB WITH BLACK FOREIGN MATTER. THERE WERE TWO OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256130 PEN NEEDLE 31GX5MM 7 PACK HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 8089376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other