BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ PEN NEEDLE

    MDR report key: 8308786 · Received February 5, 2019

    Report

    Report Number
    3006948883-2019-00122
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 25, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES WERE RECEIVED FOR INVESTIGATION, SO NO IN-DEPTH INVESTIGATION COULD BE PERFORMED. RETENTION SAMPLES WERE CHECKED ON POINT AND LUBRICATION, AND ALL RESULTS MET THE REQUIRED SPECIFICATIONS. A DHR OF LOT 7213228 WAS REVIEWED AND NO QNS OR ABNORMALITIES WERE FOUND. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ PEN NEEDLE WOULD NOT INJECT INSULIN DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96562 BD¿ PEN NEEDLE PEN NEEDLE FMI BD (SUZHOU) 7213228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other