BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE¿ ULTRA-FINE III

    MDR report key: 8612486 · Received May 15, 2019

    Report

    Report Number
    9616656-2019-00442
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III CANNULA BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320108; BATCH NO: 8143539. THE PEN NEEDLE BROKE OFF AT THE NON PATIENT END AS IT WAS BEING ATTACHED IT TO THE INSULIN PEN. THE NEEDLE HUB KEPT SPINNING RATHER THAN ATTACHING. VERBATIM: CONSUMER REPORTED THAT THE PEN NEEDLE BROKE OFF AT NON PATIENT END AS HE WAS ATTACHING IT TO THE INSULIN PEN, HE NOTICED THE PROBLEM WHEN THE NEEDLE HUB KEPT SPINNING RATHER THAN ATTACHING. THIS OCCURRED ABOUT TWO WEEKS AGO. CONSUMER DOES NOT RE-USE, SAID HE IS A LONG TIME USER OF PEN NEEDLES. LOT # 8143539, PRODUCT # 320108, EXP 05-2023. PROBLEM OCCURRED A FEW DAYS LATER WITH SAME BOX AND LOT. . HE BELIEVES THAT THE BROKEN NEEDLE IS STILL IN THE PEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III CANNULA BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320108, BATCH NO: 8143539. THE PEN NEEDLE BROKE OFF AT THE NON PATIENT END AS IT WAS BEING ATTACHED IT TO THE INSULIN PEN. THE NEEDLE HUB KEPT SPINNING RATHER THAN ATTACHING. VERBATIM: CONSUMER REPORTED THAT THE PEN NEEDLE BROKE OFF AT NON PATIENT END AS HE WAS ATTACHING IT TO THE INSULIN PEN, HE NOTICED THE PROBLEM WHEN THE NEEDLE HUB KEPT SPINNING RATHER THAN ATTACHING. THIS OCCURRED ABOUT TWO WEEKS AGO. CONSUMER DOES NOT RE-USE, SAID HE IS A LONG TIME USER OF PEN NEEDLES. LOT # 8143539, PRODUCT # 320108, EXP 05-2023. PROBLEM OCCURRED A FEW DAYS LATER WITH SAME BOX AND LOT. HE BELIEVES THAT THE BROKEN NEEDLE IS STILL IN THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404152 BD PEN NEEDLE¿ ULTRA-FINE III INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other