BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 16005555 · Received December 19, 2022

    Report

    Report Number
    9617032-2022-01288
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 22, 2022
    Report Date
    March 8, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2237490. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2022-08-25. MEDICAL DEVICE LOT #: 2171043. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2022-06-20. MEDICAL DEVICE LOT #: 2164897. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2022-06-13. 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, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR RED CELL HANG UP AND FIBRIN WAS OBSERVED. A COMPLAINT HISTORY REVIEW WAS PERFORMED AND REVEALED A CONFIRMED COMPLAINT TREND FOR SOME SAMPLE QUALITY ISSUES INCLUDING RED CELL HANG-UP. BASED ON THE CONFIRMED COMPLAINT TREND A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS INITIATED. 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 HAS BEEN CONFIRMED FOR RED CELL HANG UP AND FIBRIN BASED ON THE TREND IDENTIFIED AND THE PHOTO PROVIDED. A CORRECTIVE AND PREVENTIVE ACTION WAS CREATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS RED CELL HANG UP AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE NOTED THAT MANY SST TUBES HAVE FIBRIN DEPOSITS ON THE WALLS OR SURFACE OF THE GEL AFTER CENTRIFUGATION. THE TECHNICIANS TELL ME THAT THEY SOMETIMES HAVE TO REMOVE THICK DEPOSITS ON TOP OF THE GEL TO AVOID POTENTIAL CLOGGING OF THE AUTOMAT NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS RED CELL HANG UP AND MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE NOTED THAT MANY SST TUBES HAVE FIBRIN DEPOSITS ON THE WALLS OR SURFACE OF THE GEL AFTER CENTRIFUGATION. THE TECHNICIANS TELL ME THAT THEY SOMETIMES HAVE TO REMOVE THICK DEPOSITS ON TOP OF THE GEL TO AVOID POTENTIAL CLOGGING OF THE AUTOMAT NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588206 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 SEE H.10 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown