BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7607576 · Received June 15, 2018

    Report

    Report Number
    9617032-2018-02037
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    December 1, 2017
    Report Date
    May 11, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MEDICAL DEVICE LOT #: 7191578; MEDICAL DEVICE EXPIRATION DATE: 07/10/2017; DEVICE MANUFACTURE DATE: 12/31/2018. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT NUMBER AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: THIS COMPLAINT INVESTIGATION WAS CONDUCTED UNDER THE PREMISE OF A PREVIOUSLY INVESTIGATED ISSUE SPECIFIC FOR HEMOLYSIS, WHERE IT WAS DETERMINED THAT THE RESULTS AND CONCLUSIONS ESTABLISHED IN THE PREVIOUS INVESTIGATIONS POINTED TO THE SAME INDICATED FAILURE MODE AND ROOT CAUSES OBSERVED IN THE CURRENT COMPLAINT INVESTIGATION. ADDITIONALLY, THE CONCLUSION DRAWN FROM THE CURRENT COMPLAINT INVESTIGATION DID NOT YIELD NEW INFORMATION REGARDING THE INDICATED FAILURE MODE. COMPLAINT DATA FOR THIS FAILURE MODE IS MONITORED AND TRENDED ON A ROUTINE BASIS. ROOT CAUSE DESCRIPTION: THIS COMPLAINT INVESTIGATION WAS CONDUCTED UNDER THE PREMISE OF A PREVIOUSLY INVESTIGATED ISSUE SPECIFIC FOR HEMOLYSIS, WHERE IT WAS DETERMINED THAT THE RESULTS AND CONCLUSIONS ESTABLISHED IN THE PREVIOUS INVESTIGATIONS POINTED TO THE SAME INDICATED FAILURE MODE AND ROOT CAUSES OBSERVED IN THE CURRENT COMPLAINT INVESTIGATION. ADDITIONALLY, THE CONCLUSION DRAWN FROM THE CURRENT COMPLAINT INVESTIGATION DID NOT YIELD NEW INFORMATION REGARDING THE INDICATED FAILURE MODE. COMPLAINT DATA FOR THIS FAILURE MODE IS MONITORED AND TRENDED ON A ROUTINE BASIS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446848 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7261891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other