BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 17048885 · Received June 2, 2023

    Report

    Report Number
    9616656-2023-00532
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 2, 2023
    Report Date
    June 15, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 12-JUN-2023 H6: INVESTIGATION SUMMARY ELEVEN OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2242750, SIX OPEN 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 2180157 ALONG WITH TWO OPEN SAMPLES FROM AN UNKNOWN LOT. NO. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES FROM LOT. NO. 2242750 AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON FOUR SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING SEVEN SAMPLES. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H3. 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 · 0

    IT WAS REPORTED THAT UNSPICIFIED NUMBER OF BD ULTRA-FINE¿ PEN NEEDLES BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAS FOUND APPROXIMATELY 20 % OF THE NEEDLES IN EACH BOX BEND OR BREAK AT THE BACK END ON APPLICATION OF THE NEEDLE TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPICIFIED NUMBER OF BD ULTRA-FINE¿ PEN NEEDLES BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAS FOUND APPROXIMATELY 20 % OF THE NEEDLES IN EACH BOX BEND OR BREAK AT THE BACK END ON APPLICATION OF THE NEEDLE TO THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186032 BD ULTRA-FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2242750

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown