BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8612758 · Received May 15, 2019

    Report

    Report Number
    9616656-2019-00447
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 31, 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
    LA, US
    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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WERE USED AND CAUSED AN ALLERGIC REACTION IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122, BATCH NO: 8030929. VERBATIM: CONSUMER REPORTED THAT THE NANO PEN NEEDLES BEND EASILY AT PATIENT END, STATED THAT SHE TESTED THE STRENGTH OF THE NEEDLE BY BENDING IT AND FOUND THAT IT BENDS VERY EASILY, WANTED TO KNOW IF NEEDLE IS MADE WITH ALUMINUM. CONSUMER ALSO STATED THAT THERE ARE RED MARKS ON HER SKIN AFTER INJECTION AND SKIN ITCHES ALL OVER, CONSUMER DOES PINCH UP WHEN INJECTING WITH NANO NEEDLES. SHE SAID SHE IS GETTING AN ALLERGIC REACTION TO THE NEEDLES, STATED THAT SHE MENTIONED IT TO HER DOCTOR BUT DID NOT SEEK ANY MEDICAL ATTENTION, SHE HAS A DOCTOR'S APPOINTMENT ON (B)(6)2023. CONSUMER DOES NOT RE-USE, LOT # 8030929, PRODUCT # 320122, EXP DATE WAS NOT PROVIDED, OCCURRENCE DATE IS UNKNOWN. CONSUMER WAS ADVISED TO CONTACT US WITH ANY UPDATES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 ULTRA FINE¿ PEN NEEDLES WERE USED AND CAUSED AN ALLERGIC REACTION IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122; BATCH NO: 8030929. VERBATIM: CONSUMER REPORTED THAT THE NANO PEN NEEDLES BEND EASILY AT PATIENT END, STATED THAT SHE TESTED THE STRENGTH OF THE NEEDLE BY BENDING IT AND FOUND THAT IT BENDS VERY EASILY, WANTED TO KNOW IF NEEDLE IS MADE WITH ALUMINUM. CONSUMER ALSO STATED THAT THERE ARE RED MARKS ON HER SKIN AFTER INJECTION AND SKIN ITCHES ALL OVER, CONSUMER DOES PINCH UP WHEN INJECTING WITH NANO NEEDLES. SHE SAID SHE IS GETTING AN ALLERGIC REACTION TO THE NEEDLES, STATED THAT SHE MENTIONED IT TO HER DOCTOR BUT DID NOT SEEK ANY MEDICAL ATTENTION, SHE HAS A DOCTOR'S APPOINTMENT ON (B)(6) 2023. CONSUMER DOES NOT RE-USE, LOT # 8030929, PRODUCT # 320122, EXP DATE WAS NOT PROVIDED, OCCURRENCE DATE IS UNKNOWN. CONSUMER WAS ADVISED TO CONTACT US WITH ANY UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405083 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8030929 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other