BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PRO PEN NEEDLE

    MDR report key: 13515435 · Received February 11, 2022

    Report

    Report Number
    9616656-2022-00159
    Event Type
    Malfunction
    Date Received
    February 11, 2022
    Date of Event
    January 31, 2022
    Report Date
    May 20, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1033653. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. H.4. DEVICE MANUFACTURE DATE: 02-FEB-2021. D.4. MEDICAL DEVICE LOT #: UNKNOWN . D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H.4. DEVICE MANUFACTURE DATE: UNKNOWN . D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 17-MAY-2022. H.6. INVESTIGATION: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND ONE PHOTO WERE RETURNED FROM LOT. NO. 1033653, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTO AND A LOOSE HUB IN COVER 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. THIS ISSUE WAS CAUSED BY AN INTERFERENCE FIT BETWEEN THE HUB AND COVER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE THE OUTER COVER WAS LOOSE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE OUTER COVER WAS LOOSE AND WAS SPINNING AROUND."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE THE OUTER COVER WAS LOOSE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE OUTER COVER WAS LOOSE AND WAS SPINNING AROUND."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICRO-FINE¿+ PRO PEN NEEDLE THE OUTER COVER WAS LOOSE. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE OUTER COVER WAS LOOSE AND WAS SPINNING AROUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081734 BD MICRO-FINE¿+ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown