BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK

    MDR report key: 10075337 · Received May 20, 2020

    Report

    Report Number
    1920898-2020-00549
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 30, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903097020
    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. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 8002829 AND 8002830. 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 SYRINGE HAS MOLDING DEFECT THAT IS CAUSING IT TO LEAK DURING USE WITH A BD LUER LOK¿ 3 ML SYRINGE BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 4 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 #: 8002829, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-01-28, MEDICAL DEVICE LOT #: 8002830, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2018-02-02." 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 SYRINGE HAS MOLDING DEFECT THAT IS CAUSING IT TO LEAK DURING USE WITH A BD LUER LOK¿ 3 ML SYRINGE BULK CONVENIENCE PAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 4 COMPLAINTS) IT WAS REPORTED THAT SYRINGES HAVE MOLDING DEFECT, CAUSING THEM TO LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537424 BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 309702 SEE H.10 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other