BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES

    MDR report key: 16899519 · Received May 9, 2023

    Report

    Report Number
    9616656-2023-00463
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 2, 2023
    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

    INVESTIGATION SUMMARY TWO OPEN 32G X 4MM PEN NEEDLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. UNKNOWN CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE SAMPLES RETURNED WITH ONE BENT NON PATIENT END CANNULA AND ONE BROKEN NON PATIENT END CANNULA OBSERVED. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICRO-FINE¿ PRO PEN NEEDLES WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BENT OR BROKEN ON NPE WHEN THE USER REMOVED A TEAR DROP LABEL, THE NEEDLE WAS BROKEN ON NPE. THE NEEDLE ON NPE IS BROKEN AND INSULIN DIDN'T COME OUT WHEN THE USER PRIMED THE INSULIN PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICRO-FINE¿ PRO PEN NEEDLES WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE BENT OR BROKEN ON NPE WHEN THE USER REMOVED A TEAR DROP LABEL, THE NEEDLE WAS BROKEN ON NPE. THE NEEDLE ON NPE IS BROKEN AND INSULIN DIDN'T COME OUT WHEN THE USER PRIMED THE INSULIN PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688596 BD MICRO-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown