BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 16463861 · Received March 1, 2023

    Report

    Report Number
    9617032-2023-00221
    Event Type
    Malfunction
    Date Received
    March 1, 2023
    Date of Event
    February 14, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED; ALL SAMPLES MET SPECIFICATIONS. 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. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER 2227716 AND THE ¿AS REPORTED¿ DEFECT CODES. FURTHER CLINICAL INVESTIGATION IS NOT REQUIRED FOR THIS CLAIM AS THE WORKFLOW IS OFF-LABEL. SST II ADVANCE TUBES ARE DESIGNED TO BE STORED AT 4-25ºC (39-77ºF), UNLESS OTHERWISE NOTED ON THE PACKAGE LABEL. STORAGE OF GLASS TUBES CONTAINING BLOOD AT OR BELOW 0ºC MAY RESULT IN TUBE BREAKAGE. BD VACUTAINER® SST¿ II ADVANCE TUBES MAY BE USED FOR ROUTINE BLOOD DONOR SCREENING AND DIAGNOSTIC TESTING OF SERUM FOR INFECTIOUS DISEASE SUCH AS TORCH, SYPHILIS AB, ANTI-HIV, ANTI-HTLV, ANTI-HCV, ANTI-HBC, AND HBSAG. THE PERFORMANCE CHARACTERISTICS OF THESE TUBES HAVE NOT BEEN ESTABLISHED FOR INFECTIOUS DISEASE TESTING IN GENERAL; THEREFORE, USERS MUST VALIDATE THE USE OF THESE TUBES FOR THEIR SPECIFIC ASSAY-INSTRUMENT/REAGENT SYSTEM COMBINATIONS AND SPECIMEN STORAGE CONDITIONS. BD VACUTAINER® SST¿ II ADVANCE TUBES ARE NOT RECOMMENDED FOR IMMUNOHEMATOLOGY TESTING. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR POOR SERUM AND POOR BARRIER SEPARATION. 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 TUBE THERE WAS DISCOLORED/ABNORMAL ADDITIVE FORM AND POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SEVERAL TUBES HAVE BEEN YELLOW (AFTER CENTRIFUGATION/FREEZING/THAWING) AND THE GEL IS SEPARATING AND MIXING BETWEEN THE BLOOD CELLS AND THE SERUM."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS DISCOLORED/ABNORMAL ADDITIVE FORM AND POOR BARRIER SEPARATION OF THE SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SEVERAL TUBES HAVE BEEN YELLOW (AFTER CENTRIFUGATION/FREEZING/THAWING) AND THE GEL IS SEPARATING AND MIXING BETWEEN THE BLOOD CELLS AND THE SERUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142387 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2227716

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown