BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18234861 · Received November 29, 2023

    Report

    Report Number
    1213809-2023-01365
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 24, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION OUR QUALITY ENGINEER INSPECTED THE PHOTO AND 5 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF BARREL CRACKED/ LEAKAGE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THE PLUNGER RODS WERE DAMAGED WITH MAJOR CRACKS OR BROKEN OFF. TWO PLUNGER RODS WERE ALSO BROKEN WITH A PIECE MISSING. FOUR BARRELS HAD A NICK IN THE FLANGE AND DAMAGE TO THE SIDE OF THE BARREL, LEAKING PAST THE STOPPER. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. THE POTENTIAL ROOT CAUSE FOR THE BARREL AND PLUNGER ROD DAMAGED DEFECTS, AND LEAKAGE PAST STOPPER DEFECT ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE BARRELS WERE CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM SUBMITTING A COMPLAINT FOR GROSS DAMAGE IN OUR BD SYRINGE WE RECEIVED. THERE WERE SEVERELY CRACKED AND BROKEN SYRINGES, ALONG WITH LEAKAGE BEYOND THE PLUNGER." PRODUCT NAME: SYRINGE 10 ML LL TIP BULK CONVENIENCE PAK CATALOG NUMBER: 309605, BATCH NUMBER: 2091112, EXPIRATION DATE: 2027/03/31, MANUFACTURE DATE: 2022/04/01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846189 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2091112 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown