BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9250665 · Received October 29, 2019

    Report

    Report Number
    9616657-2019-00357
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 12, 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
    TX, 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLES CLOG DURING INJECTION WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: IT WAS REPORTED THAT NEEDLES CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES CLOGGED DURING INJECTION. COMPLETES A FLOW CHECK BUT CANNOT SEE INSULIN COMING OUT, SHE HAS VISION ISSUES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9031737, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-04-03, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN." 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 THE NEEDLES CLOG DURING INJECTION WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COMPANY REPORTER: IT WAS REPORTED THAT NEEDLES CLOGGED DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES CLOGGED DURING INJECTION. COMPLETES A FLOW CHECK BUT CANNOT SEE INSULIN COMING OUT, SHE HAS VISION ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047927 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other