BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO 2ND GEN PEN NEEDLES 4MM X 32G

    MDR report key: 11776335 · Received May 5, 2021

    Report

    Report Number
    9616656-2021-00476
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 30 BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO INSULIN FLOW WHEN PRIMING AND WHEN TAKING THE INJECTION. 30 PEN NEEDLES AFFECTED BATCH/LOT #: 0231155. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLESL: YES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. SAMPLE AVAILABLE FOR EVALUATION: NOTED AS NO - AVAILABLE SAMPLE NOT YET RECEIVED. UPON RECEIPT AND IN CONJUNCTION WITH DEVICE EVALUATION A SUPPLEMENTAL WILL BE FILED. 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 · 1

    IT WAS REPORTED THAT 30 BD NANO¿ 2ND GEN PEN NEEDLES 4MM X 32G WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS NO INSULIN FLOW WHEN PRIMING AND WHEN TAKING THE INJECTION. 30 PEN NEEDLES AFFECTED. BATCH/LOT #: 0231155. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLESL: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673507 BD NANO 2ND GEN PEN NEEDLES 4MM X 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0231155 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1