BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7614045 · Received June 19, 2018

    Report

    Report Number
    1213809-2018-00359
    Event Type
    Malfunction
    Date Received
    June 19, 2018
    Date of Event
    May 28, 2018
    Report Date
    June 22, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096046
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ONE OPEN 1ML LL PACKAGED SYRINGE WITH TIP CAP WAS RECEIVED AND CONFIRMED TO BE FROM BATCH #8001738 (P/N 309628). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE A SMALL WHITE BUBBLE LOCATED IN THE BARREL WALL ABOVE THE 0.1 ML MARKING AND ONE OPPOSITE THE 0.2 ML MARKING. BOTH ARE EMBEDDED IN THE BARREL WALL AND ARE SMALLER THAN LEVEL 3 IN SIZE, WHICH IS AN ACCEPTABLE CONDITION PER SPECIFICATION. THEY ARE CONSIDERED TO BE A COSMETIC DEFECT. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CANNOT BE VERIFIED. DHR REVIEW FOR BATCH 8001738 (P/N 309628). MANUFACTURING DATES: 01/14/2018 TO 01/15/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8001738 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ DISPOSABLE SYRINGES HAD AN OFF-WHITE SPOT STUCK TO THE INSIDE OF THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455918 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001738 00382903096046

    Patients

    Seq Age Sex Outcome Treatment
    1 Other