BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 5 ML

    MDR report key: 14875460 · Received June 30, 2022

    Report

    Report Number
    9610847-2022-00242
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 6, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 20 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. FTIR TESTING WAS PERFORMED ON THE FOREIGN MATTER TO DETERMINE ITS COMPOSITION AND RESULTS SHOWED THAT THE OBJECT WAS LIKELY A PIECE OF CARDBOARD BOX. BD CANNOT CONFIRM THAT THE CAUSE OF THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS, SINCE THE FOREIGN MATTER AND SAMPLE WERE NOT IN THE ORIGINAL PACKAGING. THOUGH THE ROOT CAUSE CANNOT BE CONFIRMED TO BE ASSOCIATED TO THE MANUFACTURING PROCESS, THERE IS A POSSIBILITY OF THIS FAILURE OCCURRING DUE TO MISHANDLING OF THE PRODUCT DURING MANUFACTURING. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 5 ML, FOREIGN MATTER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE INITIATE A NEW COMPLAINT FOR A 5ML SYRINGE WITH FOREIGN MATTER? THIS IS BD MATERIAL 309703, LOT 2090479.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 5 ML, FOREIGN MATTER WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE INITIATE A NEW COMPLAINT FOR A 5ML SYRINGE WITH FOREIGN MATTER? THIS IS BD MATERIAL 309703, LOT 2090479.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058950 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY, 5 ML PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 309703 2090479 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown