BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP FEMALE LUER LOK S/SU

    MDR report key: 20038961 · Received August 22, 2024

    Report

    Report Number
    2618282-2024-00115
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYW
    UDI-DI
    50382904085310
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IS OBSERVED IN THE PHOTO A WHITE FEMALE CAP IN AN OPEN BLISTER AND IN THE TOP PART A DARK MARK IS SEEN. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH OPERATOR ERROR DURING THE MANUAL LOAD AND FEED OF PRODUCT INTO THE BLISTER POCKET. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    MATERIAL#: 408531; BATCH NUMBER#: 2222712. IT WAS REPORTED BY CUSTOMER THAT WHILE INSPECTING PRIOR TO USE THEY FOUND BLACK PARTICLES IN SOME OF THE CAPS. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHILE INSPECTING PRIOR TO USE THEY FOUND BLACK PARTICLES IN SOME OF THE CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218466 CAP FEMALE LUER LOK S/SU CONTAINER, LIQUID MEDICATION, GRADUATED KYW BECTON DICKINSON 2222712 50382904085310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown