BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPTTM GLASS TUBE WITH BLUE/BLACK SPECKLED CONVENTIONAL CLOSURE

    MDR report key: 7059105 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00233
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    January 19, 2016
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: AN UNUSED SAMPLE WAS RETURNED FOR EVALUATION. NO ISSUES WERE DETECTED WITH THE SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5182517. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH A 510K NUMBER BUT THIS DEVICE IS PRE-AMENDMENT AND DOES NOT HAVE A 510K ASSOCIATED WITH IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPTTM GLASS TUBE WITH BLUE/BLACK SPECKLED CONVENTIONAL CLOSURE HAD ITS GLASS BREAK DURING CENTRIFUGATION. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840931 BD VACUTAINER® CPTTM GLASS TUBE WITH BLUE/BLACK SPECKLED CONVENTIONAL CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5182517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other