BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLE

    MDR report key: 14403026 · Received May 14, 2022

    Report

    Report Number
    9616656-2022-00545
    Event Type
    Malfunction
    Date Received
    May 14, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 25, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 17-MAY-2022. H.6. INVESTIGATION: FOUR SEALED 32G X 4MM PEN NEEDLE SAMPLES AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 1223671, CAT. NO. 320136. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS BROKEN BEFORE USING THE BD MICRO-FINE¿+ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: A PHARMACY STAFF DELIVERED THE PRODUCT TO A PATIENT AT HOME, AND THE NEEDLE PE WAS FOUND TO BE BROKEN IN ONE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WAS BROKEN BEFORE USING THE BD MICRO-FINE¿+ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: A PHARMACY STAFF DELIVERED THE PRODUCT TO A PATIENT AT HOME, AND THE NEEDLE PE WAS FOUND TO BE BROKEN IN ONE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899224 BD MICRO-FINE¿+ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1223671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown