BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ PEN NEEDLE

    MDR report key: 7918996 · Received September 28, 2018

    Report

    Report Number
    9616656-2018-00212
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    30382903814672
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FORTY FOUR SEALED AND INTACT 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8010972, CAT. 320141. CLOG TESTING WAS CARRIED OUT ON 30 OF THE RETURNED SAMPLES AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD MICRO-FINE ULTRA PEN NEEDLE HAD LEAKAGE BETWEEN THE NEEDLE AND THE PLASTIC HUB. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ULTRA¿ PEN NEEDLE HAD LEAKAGE BETWEEN THE NEEDLE AND THE PLASTIC HUB. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761817 BD MICRO-FINE ULTRA¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8010972 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other