BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10075007 · Received May 20, 2020

    Report

    Report Number
    1213809-2020-00323
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. 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 THE SYRINGES HAVE MOLDING DEFECTS WHICH ARE CAUSING LEAKAGE DURING USE WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS). IT WAS REPORTED THAT SYRINGES HAVE MOLDING DEFECT, CAUSING THEM TO LEAK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0003853, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-03. MEDICAL DEVICE LOT #: 0059796, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-02-28." 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 THE SYRINGES HAVE MOLDING DEFECTS WHICH ARE CAUSING LEAKAGE DURING USE WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS). IT WAS REPORTED THAT SYRINGES HAVE MOLDING DEFECT, CAUSING THEM TO LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537322 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE H.10 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other