BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7834979 · Received August 30, 2018

    Report

    Report Number
    9617032-2018-02664
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 10, 2018
    Report Date
    September 18, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FOR LOT 8128633 AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES FOR INCIDENT LOT NUMBER 8128633 WERE EVALUATED ALONG WITH RETAIN SAMPLES OF INCIDENT LOT NUMBER 8120988 (RETAINS OF THIS LOT WERE USED SINCE NO SAMPLES WERE RECEIVED FROM THE CUSTOMER FACILITY) AND RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE AS THERE WERE NO ISSUES RELATING TO POOR BARRIER SEPARATION. 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 POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION/TESTING OF THE CUSTOMER AND RETAIN SAMPLES WAS CONDUCTED AND NO ISSUES WERE OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD SEPARATION GEL THAT REMAINED AT THE BOTTOM OF THE TUBE DURING CENTRIFUGATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8128633, MEDICAL DEVICE EXPIRATION DATE: 2019-10-31, DEVICE MANUFACTURE DATE: 2018-05-08. MEDICAL DEVICE LOT #: 8120988, MEDICAL DEVICE EXPIRATION DATE: 2019-10-31, DEVICE MANUFACTURE DATE: 2018-04-30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD SEPARATION GEL THAT REMAINED AT THE BOTTOM OF THE TUBE DURING CENTRIFUGATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675212 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10. 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other