BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ PEN NEEDLE

    MDR report key: 16970476 · Received May 20, 2023

    Report

    Report Number
    2243072-2023-00835
    Event Type
    Malfunction
    Date Received
    May 20, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 18-MAY-2023. H6) INVESTIGATION SUMMARY: THREE OPEN PEN NEEDLE SAMPLES AND ONE LOOSE TEARDROP LABEL WERE RETURNED FROM LOT. NO. 2110801. VISUAL EXAMINATION OF THE RETURNED SAMPLES WAS CARRIED OUT AND IT WAS OBSERVED THAT THE LOT NUMBER AND PRODUCT WAS NOT MANUFACTURED IN DUN LAOGHAIRE. NO DHR REVIEW CAN BE CARRIED OUT AS THE LOT NUMBER 2110801 WAS NOT MANUFACTURED IN DUN LOAGHAIRE. BASED ON THE SAMPLES RETURNED NO FURTHER INVESTIGATION CAN BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCUFINE WAS DIFFICULT TO SET TO THE INSULIN PEN AND THE NEEDLE ON THE SYRINGE SIDE BENT OR BROKE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCUFINE WAS DIFFICULT TO SET TO THE INSULIN PEN AND THE NEEDLE ON THE SYRINGE SIDE BENT OR BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016836 UNSPECIFIED BD¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown