BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET 33GA

    MDR report key: 12633064 · Received October 14, 2021

    Report

    Report Number
    9616656-2021-01288
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. LOT# 6278428 WAS MANUFACTURED IN 2006 (15 YEARS SINCE CREATION DATE). AS PER MANUFACTURING, THE LOT # WOULD HAVE EXPIRED BY NOW, AND THE DHR IS NO LONGER AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LANCET 33GA EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REQUESTED ASSISTANCE LOCATING EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER STATE: THE STATE WAS DETERMINED TO BE PA BASED ON THE INITIAL REPORTER'S PHONE #. 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 LANCET 33GA EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REQUESTED ASSISTANCE LOCATING EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530306 LANCET 33GA LANCET FMK BECTON DICKINSON AND CO. 6278428

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown