BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD COLLECTION TUBE

    MDR report key: 7075807 · Received December 1, 2017

    Report

    Report Number
    1024879-2017-00349
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    August 26, 2015
    Report Date
    November 6, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. FOUR PHOTOS WERE SENT THAT SHOWED THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4171742. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER BLOOD COLLECTION TUBE 16 X 100 HAD A CHIPPED STOPPER ON THE INSIDE OF THE TUBE. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853459 BD VACUTAINER® BLOOD COLLECTION TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 4171742

    Patients

    Seq Age Sex Outcome Treatment
    1 Other