BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 9214044 · Received October 21, 2019

    Report

    Report Number
    9616656-2019-01011
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 4, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR NEEDLE CLOG. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NOTHING CAME OUT OF PEN NEEDLE DURING PRIMING. ISSUE: NOTHING CAME DURING THE PRIMING, SAMPLE DISCARDED. INCIDENT DATE: UNKNOWN. OCCURENCE: UNKNOWN. ITEM#: 320122. LOT#: 9092785; EXPIRATION DATE: 2024-03-31. CONSUMER USES THE NEW NEEDLE FOR HIS INJECTION, PARENT VISUALLY SEES IF IT IS STRAIGHT YES. CONSUMERS FATHERS ATTACHES THE PEN NEEDLE TIGHTLY. EXPLAINED THE CALLER, NOT TO ATTACH IT TIGHTLY BUT A FIRM ATTACHMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NOTHING CAME OUT OF PEN NEEDLE DURING PRIMING. ISSUE: NOTHING CAME DURING THE PRIMING, SAMPLE DISCARDED. INCIDENT DATE: UNKNOWN, OCCURENCE: UNKNOWN, ITEM#: 320122, LOT#: 9092785;EXPIRATION DATE: 2024-03-31. CONSUMER USES THE NEW NEEDLE FOR HIS INJECTION, PARENT VISUALLY SEES IF IT IS STRAIGHT YES. CONSUMERS FATHERS ATTACHES THE PEN NEEDLE TIGHTLY. EXPLAINED THE CALLER, NOT TO ATTACH IT TIGHTLY BUT A FIRM ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010884 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9092785 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other