BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7575627 · Received June 6, 2018

    Report

    Report Number
    1024879-2018-02132
    Event Type
    Malfunction
    Date Received
    June 6, 2018
    Date of Event
    January 3, 2018
    Report Date
    July 23, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7083504, EXPIRATION DATE: 03/31/2018, MANUFACTURE DATE: 03/24/2017. INITIAL REPORTER PHONE #: (B)(6). 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 AIR BUBBLES IN THE SEPARATOR GEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR AIR BUBBLES IN THE SEPARATOR GEL WITH THE INCIDENT LOT WAS 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR GEL AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. THE CUSTOMER SAMPLES WERE TESTED AND NO ISSUES RELATING TO GEL AIR BUBBLES WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. 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 GEL AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED AND GEL AIR BUBBLES WAS 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 · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AIR BUBBLES IN THE GEL. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD AIR BUBBLES IN THE GEL. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417669 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 7061934 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other