BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15538489 · Received October 4, 2022

    Report

    Report Number
    9617032-2022-00951
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 20, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 367954. LOT/BATCH #: 2040813. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE RELATING TO DAMAGED TUBES WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER NOTICED THAT IT WAS LEAKING AT THE BOTTOM OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿PATHOLOGY COLLECTOR USED A 5ML SSTII TUBE ON A PATIENT AND NOTICED IT WAS LEAKING AT THE BOTTOM OF THE TUBE. TAPED THE TUBE BACK TOGETHER AND SENT THIS INTO THE LAB. THIS WAS THEN REJECTED BY THE LAB AS BLOOD/ADDITIVE WAS LEAKING OUT OF TUBE. THIS RESULTED IN A RECOLLECTION ON THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES CUSTOMER NOTICED THAT IT WAS LEAKING AT THE BOTTOM OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿PATHOLOGY COLLECTOR USED A 5ML SSTII TUBE ON A PATIENT AND NOTICED IT WAS LEAKING AT THE BOTTOM OF THE TUBE. TAPED THE TUBE BACK TOGETHER AND SENT THIS INTO THE LAB. THIS WAS THEN REJECTED BY THE LAB AS BLOOD/ADDITIVE WAS LEAKING OUT OF TUBE. THIS RESULTED IN A RECOLLECTION ON THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507414 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2040813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown