BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7914558 · Received September 27, 2018

    Report

    Report Number
    1213809-2018-00638
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 7, 2018
    Report Date
    October 12, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FIVE LOOSE 10ML ASSEMBLED SYRINGES, THREE WITH TIP CAP ATTACHED, WERE RECEIVED AND REPORTED TO BE FROM BATCH #8143663 (P/N 309605). THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO CONTAIN A SMALL AMOUNT OF CLEAR LIQUID RESIDUE IN THE FLUID PATH OF THE SYRINGE. THE SYRINGES WERE EVALUATED FOR LEAKAGE INCLUDING EVIDENCE LEAKAGE MAY HAVE OCCURRED. 3 SYRINGES HAVE NO OBSERVED DEFECTS INCLUDING RESIDUE FROM LEAKAGE. 2 SYRINGES WERE FOUND TO HAVE LIQUID RESIDUE BETWEEN THE STOPPER RIBS. FLUID PAST THE FRONT RIB OF THE STOPPER IS REJECTABLE PER PRODUCT SPECIFICATION. THE PLUNGER ROD OF ALL 5 SAMPLES WAS MOVED TO VERIFY STOPPER SEAL. ALL SYRINGE FUNCTIONED AS EXPECTED. NO OTHER TESTING WAS PERFORMED BECAUSE SAMPLES APPEAR USED. 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. POTENTIAL ROOT CAUSE FOR THE LEAKAGE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. 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 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS, HAD LEAKS FROM THE PLUNGERS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS, HAD LEAKS FROM THE PLUNGERS. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754332 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8143663 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other