BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD K2EDTA BLOOD COLLECTION TUBE

    MDR report key: 6787365 · Received August 11, 2017

    Report

    Report Number
    1917413-2017-00105
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    May 20, 2015
    Report Date
    January 31, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: A ROOT CAUSE FOR THIS INCIDENT HAS NOT YET BEEN DETERMINED. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. IN SUBSEQUENT CONVERSATION WITH THE ASSAY DEVELOPER ON MAY 27, 2015, THE ASSAY DEVELOPER INDICATED THAT THE RESULTS BEING OBTAINED WERE IN RELATION TO TESTING CONDUCTED FOR A DEVELOPMENTAL DEVICE THAT HAD NOT YET LAUNCHED AND WAS NOT AVAILABLE ON THE MARKET. BD PAS PROVIDED SAMPLE TUBES TO THE ASSAY DEVELOPER FOR ITS FURTHER DEVELOPMENT WORK IN CONTINUING COMMUNICATIONS THROUGH DECEMBER 2015. BECAUSE THE ASSAY DEVELOPER DESCRIBED ISSUES WITH A DEVELOPMENTAL ASSAY AND ITS POTENTIAL INCOMPATIBILITY WITH BD VACUTAINER® K2EDTA TUBES, THE 2015 COMMUNICATIONS WERE NOT DETERMINED AT THAT TIME TO BE MDR REPORTABLE. THIS MDR IS LINKED TO (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BD PAS R&D GROUP CONDUCTED AN INVESTIGATION WITH THE OBJECTIVE BEING TO IDENTIFY THE ROOT CAUSE OF NEGATIVE BIAS OBSERVED WITH BD VACUTAINER® K2EDTA LAVENDER AND TAN TOP TUBES WHEN USED WITH LEADCARE® ULTRA TEST SYSTEM. NO BIAS WAS OBSERVED BETWEEN TUBE TYPES WHEN USING ICP-MS METHOD. FINDINGS FROM THE INVESTIGATION WERE THAT THE NEGATIVE BIAS OBSERVED WITH THE MAGELLAN¿S TEST SYSTEM IS ASSOCIATED WITH THE RUBBER CURING AGENT, THIURAM, USED IN STOPPER MANUFACTURING. THIURAM HAS BEEN USED AS A CURING AGENT IN THE LAVENDER/TAN TUBE STOPPER FORMULATION SINCE 1996 AND DOES CAUSE INTERFERENCE WITH ANODIC STRIPPING VOLTAMMETRY (ASV) METHODOLOGY (AS USED IN MAGELLAN LEADCARE INSTRUMENTS). FOR MORE INFORMATION ON THIS TECHNOLOGY PLEASE REFER TO FDA¿S SAFETY NOTICE: HTTPS://WWW.FDA.GOV/MEDICALDEVICES/SAFETY/ALERTSANDNOTICES/UCM558733.HTM.

    Description of Event or Problem · 1

    BD PAS RECEIVED A COMMUNICATION ABOUT AN ASSAY DEVELOPER NOTING VARIABILITY IN THEIR RESULTS WHEN USING AN ASSAY WITH CERTAIN K2 EDTA (3 ML) TUBES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570739 UNSPECIFIED BD K2EDTA BLOOD COLLECTION TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other