BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17234688 · Received June 29, 2023

    Report

    Report Number
    9617032-2023-00817
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 14, 2023
    Report Date
    July 27, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-07-12. H.6. INVESTIGATION SUMMARY: BD RECEIVED (B)(4) FOR INVESTIGATION. EVALUATION OF THE ATTACHED PHOTOGRAPH SHOWED(B)(4) TUBES - (B)(4) OF THEM HAD BUBBLES IN THE GEL AT ITS BASE, AND (B)(4) TUBE WAS OBSERVED WITH INSUFFICIENT GEL. EVALUATION OF RETURNED SAMPLES INDICATED (B)(4) HAD BUBBLES IN THE GEL AND (B)(4) HAD AN INSUFFICIENT GEL. ADDITIONALLY, (B)(4) WERE VISUALLY INSPECTED, AND (B)(4) TUBES CONTAINING BUBBLES IN THE GEL WERE FOUND. 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 GEL AIR BUBBLES AND INSUFFICIENT GEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAVE BUBBLES IN GEL, SOME HAS INSUFFICIENT GEL, AND SOME TUBES FEEL STICKY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BUBBLES IN GEL CUSTOMER WOULD LIKE TO INFORM THAT THEY ARE CURRENTLY INVESTIGATING A QUALITY DEFECT FOUND IN THE SERUM GEL TUBES: (B)(6) NOTICED THAT THE 5 ML SERUM GEL TUBES (REF 368498) HAVE INCORRECT TUBES IN LOT 2332698. THERE ARE EITHER AIR BUBBLES IN THE GEL, OR THERE IS TOO LITTLE GEL IN THE TUBE. APPARENTLY, GEL HAS ALSO BEEN SPILLED ON THE OUTER SURFACES OF THE TUBES DURING MANUFACTURING, AS SOME OF THE TUBES FEEL STICKY."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAVE BUBBLES IN GEL, SOME HAS INSUFFICIENT GEL, AND SOME TUBES FEEL STICKY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BUBBLES IN GEL CUSTOMER WOULD LIKE TO INFORM THAT THEY ARE CURRENTLY INVESTIGATING A QUALITY DEFECT FOUND IN THE SERUM GEL TUBES: (B)(4) LABORATORY NOTICED THAT THE 5 ML SERUM GEL TUBES (REF (B)(4)) HAVE INCORRECT TUBES IN LOT 2332698. THERE ARE EITHER AIR BUBBLES IN THE GEL, OR THERE IS TOO LITTLE GEL IN THE TUBE. APPARENTLY, GEL HAS ALSO BEEN SPILLED ON THE OUTER SURFACES OF THE TUBES DURING MANUFACTURING, AS SOME OF THE TUBES FEEL STICKY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278476 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2332698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown