BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE

    MDR report key: 12783015 · Received November 9, 2021

    Report

    Report Number
    1213809-2021-00760
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903050604
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. INVESTIGATION SUMMARY: ONE SEALED PACKAGED 3ML SYRINGE WITH BLUNT FILL NEEDLE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #9030615 (P/N 305060). THE SYRINGE WAS TAKEN OUT OF THE PACKAGE AND VISUALLY EVALUATED. NO DAMAGE, DEFORMITIES, OR OTHER DEFECTS WERE OBSERVED IN THE SAMPLE THAT COULD CONTRIBUTE TO LEAKAGE AT LUER. THE SYRINGE WAS THEN TESTED FOR LEAKAGE PER PROCEDURE. THE SYRINGE PASSED THE TEST WITH NO LEAKAGE OBSERVED. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED ENCOUNTERED A LEAK WHILE USING BD 3 ML LUER LOCK SYRINGE WHEN ATTACHED TO THE BD MAXZERO MICROBORE EXTENSION SET TUBING. VERBATIM: WE ENCOUNTERED A LEAK WHILE USING BD 3 ML LUER LOCK SYRINGE WHEN ATTACHED TO THE BD MAXZERO MICROBORE EXTENSION SET TUBING. CEFTAZIDIME WAS INFUSING IN A PATIENT OVER 30 MINUTES AND AT THE END OF INFUSION, FLUID WAS NOTED ON THE SYRINGE, TUBING, AND IV SYRINGE PUMP. PATIENT WAS NOT HARMED. HOWEVER PATIENT WAS BEING TREATED FOR BLOOD CULTURE POSITIVE BACTEREMIA AND WE BELIEVE THE ENTIRE DOSE OF ANTIBIOTIC WAS NOT ADMINISTERED TO THE PATIENT DUE TO THE LEAK. THE REPORT THAT 3ML SYRINGES LEAKING WITH MAXZERO/ MICROBORE TUBING WAS CONFIRMED AND REPRODUCED WITH THE RECEIVED EVENT PRODUCTS. THE IDENTIFIED CAUSE OF THE LEAK WAS DUE TO AN ISOLATED MOLDING ISSUE OCCURRING DURING SYRINGE MANUFACTURING. NO ISSUES WERE IDENTIFIED WITH THE MICROBORE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677923 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED BD¿ BLUNT FILL NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9030615 00382903050604

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown