BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ W/ GOLD HEMOGARD

    MDR report key: 7070442 · Received November 30, 2017

    Report

    Report Number
    1024879-2017-00265
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    January 8, 2016
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS RETURNED TO BD FOR EVALUATION ALONG WITH A PHOTO, SHOWING THE CUSTOMERS INDICATED FAILURE OF A MISSING LABEL. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5232611 . CONCLUSION: COMPLAINT CONFIRMED. THE MOSTLY LIKELY CAUSE IS A BROKEN LABEL STOCK CAUSED BY A JAM DURING LABEL PLACEMENT DURING THE TULIP PROCESS. A VISION SENSOR HAS BEEN INSTALLED TO DETECT TUBES WITHOUT LABELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL WAS MISSING ON A BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ SERUM SEPARATION TUBES WITH A GOLD HEMOGARD CLOSURE. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852557 BD VACUTAINER¿ VENOUS BLOOD COLLECTION TUBES: SST¿ W/ GOLD HEMOGARD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5232611 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other