BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS

    MDR report key: 7986812 · Received October 19, 2018

    Report

    Report Number
    1213809-2018-00679
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 1, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903034056
    PMA / PMN Number
    K924439
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPENED BLISTERPACK CONTAINING A 10ML SYRINGE WITH NEEDLE ATTACHED WAS RECEIVED IN AN ENVELOPE. THE PACKAGE WAS CONFIRMED TO BE FROM BATCH #8010900 (P/N 303405). STOPPER WAS OBSERVED TO HAVE A LARGE PIECE OF FOREIGN MATTER ATTACHED TO THE TOP, IN THE FLUID PATH. THE FOREIGN MATTER APPEARED TO BE A LARGE PIECE OF TAPE, LARGER THAN LEVEL 3 IN SIZE. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS CONTAINED FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826000 BD¿ 10 ML SYRINGE WITH INTERLINK® VIAL ACCESS HYPODERMIC SYRINGE WITH NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8010900 30382903034056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other