BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® FC BEADS 7-COLOR KIT

    MDR report key: 16381065 · Received February 15, 2023

    Report

    Report Number
    2916837-2023-00037
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 27, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906629616
    PMA / PMN Number
    K170974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2916837-2023-00037 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    PMA/510(K)# K170974, K201814 . 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD® FC BEADS 7-COLOR KIT THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM PERFORMING REFERENCE SETTING UPDATES AND NOTED THE FOLLOWING WITH THIS LOT#2339327 OF 7 COLOUR FC BEADS WHEN I USED THE BARCODE STICKER TO ADD THE NEW FC BEAD LOT INFORMATION THE TUBE LOT #S IN THE BOX DID NOT MATCH THE LOT NUMBERS FROM THE SCANNED BARCODE. WHEN I WENT AND DOWNLOADED THE BEAD-LOT FILE FROM ONLINE, IT WAS CORRECT. JUST WANTED TO GIVE YOU A HEADS UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD® FC BEADS 7-COLOR KIT THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM PERFORMING REFERENCE SETTING UPDATES AND NOTED THE FOLLOWING WITH THIS LOT#2339327 OF 7 COLOUR FC BEADS WHEN I USED THE BARCODE STICKER TO ADD THE NEW FC BEAD LOT INFORMATION THE TUBE LOT#' S IN THE BOX DID NOT MATCH THE LOT NUMBERS FROM THE SCANNED BARCODE. WHEN I WENT AND DOWNLOADED THE BEAD-LOT FILE FROM ONLINE, IT WAS CORRECT. JUST WANTED TO GIVE YOU A HEADS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205815 BD® FC BEADS 7-COLOR KIT NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 662961 2339327 00382906629616

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown