BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 15573146 · Received October 10, 2022

    Report

    Report Number
    1024879-2022-00595
    Event Type
    Malfunction
    Date Received
    October 10, 2022
    Date of Event
    September 29, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER SEPARATION WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, POOR BARRIER BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. ALL TUBES PERFORMED AS EXPECTED. 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 POOR BARRIER SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR BARRIER SEPARATION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT GEL STILL SITTING AT THE BOTTOM OF TUBE AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER REPORTS THAT GEL STILL SITTING AT BOTTOM OF TUBE AFTER CENTRIFUGATION FOR CAT 367986, LOT 2200851."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT GEL STILL SITTING AT THE BOTTOM OF TUBE AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER REPORTS THAT GEL STILL SITTING AT BOTTOM OF TUBE AFTER CENTRIFUGATION FOR CAT 367986 LOT 2200851."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272658 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 2200851 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown