BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 8833944 · Received July 26, 2019

    Report

    Report Number
    9617032-2019-00849
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903643054
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE MANUFACTURER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED RED CELL RINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RED CELL RINGS AND FIBRIN FILAMENTS APPEARED IN THE WALL OF THE BLOOD COLLECTION VESSEL AFTER CENTRIFUGATION AND EXTRACTION OF THE COVER. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE, MEDICAL DEVICE TYPE: JKA, MEDICAL DEVICE CATALOG #: 367812, MEDICAL DEVICE LOT #: 8340749, MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD), MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, UNIQUE IDENTIFIER (UDI) #: (B)(4), MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD) AND PMA/510(K)#: BK050036. DEVICE MANUFACTURE DATE: 2018-12-06.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES EXPERIENCED RED CELL RINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RED CELL RINGS AND FIBRIN FILAMENTS APPEARED IN THE WALL OF THE BLOOD COLLECTION VESSEL AFTER CENTRIFUGATION AND EXTRACTION OF THE COVER.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR RED CELL RING WITH THE INCIDENT LOT WAS OBSERVED. 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-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR RED CELL RING WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED INVOLVING MANUFACTURING. 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 AN UNSPECIFIED NUMBER OF BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M EXPERIENCED RED CELL RINGS WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RED CELL RINGS AND FIBRIN FILAMENTS APPEARED IN THE WALL OF THE BLOOD COLLECTION VESSEL AFTER CENTRIFUGATION AND EXTRACTION OF THE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623957 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8340749 50382903643054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other