BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 8085959 · Received November 19, 2018

    Report

    Report Number
    3006948883-2018-00270
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 5, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMF
    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 · 0

    RETURNED SAMPLES WERE RECEIVED ON 06NOV2018, AND PRODUCT LOT# WAS 8030466. DHR REVIEWED. THE PRODUCTION PROCESS AND IN-PROCESS INSPECTION SHOWED NO THE ABNORMAL ACTIVITIES. CHECKED THE RETAIN SAMPLES AND THERE ARE NO DEFECT FINDINGS. ANALYZE THE COMPLAINT RETURN SAMPLES, WHICH IS BLACK DOTS OF CARBIDE MATERIAL EMBEDDED IN THE PLASTIC PART. THIS IS CONSIDERED A COSMETIC DEFECT AND WILL NOT IMPACT USE OF THE DEVICE. NO FORMAL CAPA IS NEEDED. INTERNAL CORRECTIVE ACTION HAS BEEN TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD MICRO-FINE PEN NEEDLE HAD FOREIGN MATTER LIKE RUST ON IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 BD MICRO-FINE¿ PEN NEEDLE HAD FOREIGN MATTER LIKE RUST ON IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922871 BD MICRO-FINE¿ PEN NEEDLE INSULIN PEN NEEDLE FMF BD (SUZHOU) 8030466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other