BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    MDR report key: 15870415 · Received November 28, 2022

    Report

    Report Number
    2916837-2022-00356
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903357758
    PMA / PMN Number
    K040026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 2916837-2022-00356 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. PMA / 510(K)#: K040026, K141468.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS THAT THE LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS THAT THE LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER ON TUBE DOES NOT MATCH VALUE PRINTED ON INDIVIDUAL TUBE WRAPPER THE TUBE IS SEALED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743043 BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS FLOW CTYOMETRIC REAGENTS AND ACESSORIES GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 335775 85543 00382903357758

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown