BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13534410 · Received February 15, 2022

    Report

    Report Number
    9616656-2022-00172
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 10, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K213156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1145128. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-05-25. MEDICAL DEVICE LOT #: 1132269. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-05-12.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1145128. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-05-25. MEDICAL DEVICE LOT #: 1132269. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-05-12.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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 4 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. OVER THE PAST MANY MONTHS ABOUT 30% OF THE NEEDLES HAVE BEEN DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. OVER THE PAST MANY MONTHS ABOUT 30% OF THE NEEDLES HAVE BEEN DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD NANO¿ 2ND GEN PEN NEEDLES WERE UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. OVER THE PAST MANY MONTHS ABOUT 30% OF THE NEEDLES HAVE BEEN DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875711 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 SEE H10 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown