BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE PLUS PEN NEEDLE

    MDR report key: 9661648 · Received February 3, 2020

    Report

    Report Number
    9616656-2020-00072
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 14, 2020
    Report Date
    April 10, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : EIGHTY FOUR SEALED AND ONE OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9141565, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE EIGHTY-FOUR SEALED SAMPLES AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION OF THE OPEN SAMPLE WAS ALSO CARRIED OUT AND EVIDENCE OF A TEARDROP LABEL BEING APPLIED TO THE COVER WAS OBSERVED. AS PER MANUFACTURING, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE PLUS¿ PEN NEEDLE WAS MISSING THE INNER SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INNER SHIELD WAS MISSING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICRO-FINE PLUS¿ PEN NEEDLE WAS MISSING THE INNER SHIELD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INNER SHIELD WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126055 BD MICRO-FINE PLUS PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9141565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other