BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CITRATE TUBE

    MDR report key: 7085781 · Received December 5, 2017

    Report

    Report Number
    9617032-2017-00316
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    July 25, 2016
    Report Date
    November 25, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. 10 RETAINED SAMPLES WERE DRAWN WITH DEIONIZED WATER, BEFORE BEING CENTRIFUGED AT 2988 RPM FOR 15 MINUTES. NONE OF THE TUBES BROKE OR CRACKED, AND NO DAMAGE TO THE NECKS OF THE TUBES UNDER THE CAPS/STOPPERS WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5180326. CONCLUSION: WITHOUT A CUSTOMER 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 BD VACUTAINER® CITRATE TUBE WAS CRACKED OR BROKEN UNDER THE STOPPER CAUSING BLOOD TO LEAK. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862483 BD VACUTAINER® CITRATE TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5180326

    Patients

    Seq Age Sex Outcome Treatment
    1 Other