BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12447813 · Received September 9, 2021

    Report

    Report Number
    1911916-2021-00964
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 3, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE IS FOREIGN MATTER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A PIECE OF PLASTIC, ROUND IN SHAPE, AT THE BOTTOM OF THE SYRINGE BARREL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A MISALIGNMENT WHEN THE PLUNGER ROD WAS BEING ASSEMBLED TO THE SYRINGE BARREL INDUCING THE DAMAGE AND CREATING THE PIECE OF PLASTIC FOUND. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 1112982. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE PLUNGER ROD ASSEMBLY PROCESS WAS PERFORMED FINDING SETTINGS AND ALIGNMENT CORRECT. THE PRODUCT FLOW WAS ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ TIP SYRINGE THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FOREIGN MATTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343354 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 1112982 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1