BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER-LOK SYRINGE

    MDR report key: 7310216 · Received March 2, 2018

    Report

    Report Number
    1911916-2018-00058
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 8, 2018
    Report Date
    March 20, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWENTY NINE SAMPLES WERE RECEIVED BY THE MANUFACTURING PLANT FOR EVALUATION. A QUALITY ENGINEER INSPECTED THE SAMPLES AND DETERMINED THAT THE SAMPLES WERE MISSING LESS THAN 50% OF THE SCALE MARKINGS THUS VERIFYING THE REPORTED ISSUE. MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. A DEVICE HISTORY RECORD WAS PERFORMED ON THE REPORTED BATCH 7170605 AND ZERO DEFECTS WERE FOUND. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    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 DURING USE OF A BD¿ LUER-LOK SYRINGE¿ THE SCALE MARKING PRINT IS INCOMPLETE IN 29 SYRINGES.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154773 BD¿ LUER-LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7170605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other