BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD COLLECTION TUBES.

    MDR report key: 7080550 · Received December 4, 2017

    Report

    Report Number
    1917413-2017-00453
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    December 27, 2016
    Report Date
    April 4, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K901449A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE DURING MANUFACTURING OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(6). BD RECEIVED RELATIVE SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION IN SUPPORT OF THIS COMPLAINT. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LOOSE TUBE CAPS WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6161932. 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 TUBES HAD SEVERAL CAPS THAT WERE VERY LOOSE. NO MEDICAL INTERVENTION, BLOOD EXPOSURE OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858576 BD VACUTAINER® BLOOD COLLECTION TUBES. BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 6161932

    Patients

    Seq Age Sex Outcome Treatment
    1 Other