BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8871436 · Received August 7, 2019

    Report

    Report Number
    2243072-2019-01629
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 20, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, TEN RETENTION SAMPLES ARE TESTED FOR LEAKAGE AND FOR DEFECTS ON MOLDING FOR BARREL, PLUNGER ROD AND/OR STOPPER AFFECTING FUNCTIONALITY OR SAFETY FOR THE FINISHED PRODUCT, NO DEFECT OBSERVED, AND RESULTS ARE COMPLIANT. FURTHERMORE, 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. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKING WHEN FLUSHING WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2) LEAKAGE OF PRODUCTS WITH MAXZERO WHEN FLUSHING WITH 3ML AND 1ML SYRINGES.

    Additional Manufacturer Narrative · 1

    PMA / 510(K)#: K151766 (IF MANUFACTURED IN (B)(4)) K980987 (IF MANUFACTURED IN (B)(4)). 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 THERE WAS LEAKING WHEN FLUSHING WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2). LEAKAGE OF PRODUCTS WITH MAXZERO WHEN FLUSHING WITH 3 ML AND 1 ML SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666476 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON 8330522 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other