BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE PLUS INSULIN PEN NEEDLE

    MDR report key: 11712961 · Received April 23, 2021

    Report

    Report Number
    9616656-2021-00426
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: H.6. IMDRF ANNEX A GRID: A0401 / A0203. H.6. INVESTIGATION: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 0203701, CAT. NO.320136. A CLOG TEST WAS CARRIED OUT ON THE RETURNED SAMPLE AS PER TP700483 AND NO ISSUES WERE OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE RETURNED SAMPLE AND A DAMAGED HUB WAS 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. DAMAGE TO THE HUB WAS CAUSED BY AN INTERFERENCE FIT BETWEEN THE HUB AND COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICINE DIDN'T COME OUT WHEN USING THE BD MICRO FINE PLUS¿ INSULIN PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: WHEN THE CUSTOMER "ATTACHED A PEN NEEDLE TO PEN (FORTEO) AND USED IT FOR INJECTION THE DRUG DIDN'T COME OUT."

    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 MEDICINE DIDN'T COME OUT WHEN USING THE BD MICRO FINE PLUS" INSULIN PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN THE CUSTOMER "ATTACHED A PEN NEEDLE TO PEN (FORTEO) AND USED IT FOR INJECTION THE DRUG DIDN'T COME OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613647 BD MICRO FINE PLUS INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0203701

    Patients

    Seq Age Sex Outcome Treatment
    1