BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 8057079 · Received November 9, 2018

    Report

    Report Number
    1213809-2018-00756
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 18, 2018
    Report Date
    December 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095989
    PMA / PMN Number
    K980987
    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

    15 LOOSE 3ML SYRINGES WITH NEEDLES ATTACHED AND 1 OPENED EMPTY BLISTERPACK WERE RECEIVED INSIDE A ZIP LOCK BAG. THE BLISTERPACK WAS FROM BATCH #8092918 (P/N 309598). THE SAMPLES WERE VISUALLY EVALUATED THROUGH THE BAG. SOME OF THE NEEDLES APPEARED LOOSELY ATTACHED WHILE OTHERS WERE ALMOST FLUSH THE LUER COLLAR. NO VISUAL DEFECTS WERE OBSERVED. NO ADDITIONAL EVALUATION COULD BE PERFORMED DUE TO POTENTIALLY CONTAMINATED NATURE OF THE SAMPLES. NO TESTS COULD BE PERFORMED DUE TO THE RISK OF HANDLING THE POTENTIALLY CONTAMINATED SAMPLES. NO REPRESENTATIVE SEALED SAMPLES FROM THE 2 REPORTED BOXES OF THE SAME LOT WERE RETURNED FOR EVALUATION AND TESTING. 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. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD 2 CASES OF BD LUER-LOK SYRINGES WITH ATTACHED NEEDLES WITH LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 CUSTOMER HAD 2 CASES OF BD LUER-LOK¿ SYRINGES WITH ATTACHED NEEDLES WITH LEAKAGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897450 BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 8092918 30382903095989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other