BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 15859383 · Received November 23, 2022

    Report

    Report Number
    9617032-2022-01193
    Event Type
    Malfunction
    Date Received
    November 23, 2022
    Date of Event
    November 8, 2022
    Report Date
    December 8, 2022
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CARRIED OUT ON ALL THE IMPLICATED LOT NUMBERS (MANUFACTURED ON LINE 1) ASSOCIATED WITH THE RECENT INCREASE IN SAMPLE QUALITY COMPLAINTS BEING REPORTED ON 367955 SSTII TUBES. THIS REVIEW IDENTIFIED, FROM IN-PROCESS CHECKS, THAT ON EACH LOT NUMBER THE CORRECT AMOUNT OF ADDITIVE WAS DISPENSED INTO THE TUBES. A REVIEW OF THE ADDITIVE MIXING RECORDS FOR THESE LOTS ALSO CONFIRMED THAT THE ADDITIVE SUSPENSION WAS MANUFACTURED CORRECTLY, PRIOR TO BEING DISPENSED INTO THE TUBES. A VISUAL COMPARISON OF IMPLICATED TUBES AGAINST THE SAME CATALOGUE NUMBER MANUFACTURED ON A DIFFERENT LINE INDICATED A POTENTIAL DIFFERENCE IN THE SPRAY HEIGHT OF THE ADDITIVE ON THE INSIDE OF THE TUBE WALL, WITH THE IMPLICATED TUBES HAVING A LOWER PATTERN. CLINICAL EVALUATION OF THESE TWO GROUPS OF TUBES SHOWED THAT TUBES FROM THE SUSPECT MANUFACTURING LINE WERE MORE PRONE TO RED CELL HANG UP / RING THAN TUBES ASSEMBLED ON A DIFFERENT LINE, DUE TO SPRAY PATTERN OBSERVED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS THEREFORE OPENED TO INVESTIGATE THIS PHENOMENON. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE RED CELL HANG UP. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

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

    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. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE CURRENTLY HAVE ONE CLAIM PENDING (TW CLAIM NO. 6142565) IN ADDITION TO TODAY'S CLAIM WHERE WE HAVE THE SAME PROBLEM AGAIN WITH A NEW BATCH. LOT N° 2237418 EXPIRY DATE (B)(6) 2024. YOUR REF: (B)(4).

    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. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE CURRENTLY HAVE ONE CLAIM PENDING ((B)(4)) IN ADDITION TO TODAY'S CLAIM WHERE WE HAVE THE SAME PROBLEM AGAIN WITH A NEW BATCH. LOT N° 2237418 EXPIRY DATE 29/02/2024. YOUR REF: (B)(4). "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918772 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 2237418 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown