BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO PRO ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 8484848 · Received April 4, 2019

    Report

    Report Number
    9616656-2019-00308
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 16, 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 DURING USE OF THE BD NANO PRO ULTRA-FINE¿ PEN NEEDLE THERE WAS NO INSULIN FLOWING DURING INJECTION. THERE WERE 6 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ITEM 320555 LOT # 8171669 EXP 2023-06-30 DISCARDED 5 BUT KEPT 1 PEN NEEDLE WITH INSULIN NOT COMING OUT DURING INJECTION. SHE THEN REMOVES THE NEEDLE AND CHANGES THE PEN NEEDLE THAT ONE WORKS. READ PRIVACY STATEMENT. SENDING MAILING KIT FOR 1 PEN NEEDLE WITH ISSUE HUSBAND FEELS THE NON PATIENT END IS STRAIGHT. ADVISED PROPER PLACEMENT. SENDING REPLACEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD NANO PRO ULTRA-FINE¿ PEN NEEDLE THERE WAS NO INSULIN FLOWING DURING INJECTION. THERE WERE 6 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ITEM 320555, LOT # 8171669, EXP 2023-06-30, DISCARDED 5 BUT KEPT 1 PEN NEEDLE WITH INSULIN NOT COMING OUT DURING INJECTION. SHE THEN REMOVES THE NEEDLE AND CHANGES THE PEN NEEDLE THAT ONE WORKS. READ PRIVACY STATEMENT. SENDING MAILING KIT FOR 1 PEN NEEDLE WITH ISSUE HUSBAND FEELS THE NON PATIENT END IS STRAIGHT. ADVISED PROPER PLACEMENT. SENDING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274570 BD NANO PRO ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8171669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other