BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 8016082 · Received October 29, 2018

    Report

    Report Number
    3006948883-2018-00237
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 19, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BASED ON THE SAMPLE REVIEW, THE DEFECT WAS FOUND TO BE A LOOSE PARTICLE OF TEARDROP LABEL INSTEAD OF RUST AS THE CUSTOMER CLAIMED. THE PARTICLE IS PURPLE AND GREEN GIVING IT THE BROWN APPEARANCE OF RUST. THIS DEFECT IS BELIEVED TO HAVE OCCURRED IN THE MANUFACTURING PROCESS. DHR OF LOT 8030466 WAS REVIEWED AND NO QN FOUND. INVESTIGATION CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: THE DEFECT WAS CAUSED BY A MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD MICRO-FINE¿ PEN NEEDLE WAS RUSTY OUT OF THE PACKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857801 BD MICRO-FINE¿ PEN NEEDLE INSULIN PEN NEEDLE FMI BD (SUZHOU) 8030466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other