BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11741823 · Received April 28, 2021

    Report

    Report Number
    1024879-2021-00282
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD RECEIVED APPROXIMATELY 50 SAMPLES FOR THE INVESTIGATION. THE SAMPLES WERE KEPT AT FRANKLIN LAKES FOR FURTHER TESTING. THE CUSTOMER SAMPLES WERE TESTED AND NO ISSUES RELATING TO FIBRIN WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FIBRIN/FIBRIN CLOTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. EVALUATION OF BOTH CUSTOMER AND CONTROL SAMPLES TESTED WERE ACCEPTABLE. ALL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. 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 NOT CONFIRMED WITH RESPECT TO FIBRIN/FIBRIN CLOTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367986, BATCH NO. 1011493 . IT IS REPORTED CUSTOMER EXPERIENCED FIBRIN ISSUES. CUSTOMER IS EXPERIENCING ISSUES WITH 367986. THEY ARE WAITING OVER 30 MINUTES PRIOR TO SPINNING AND STILL HAVING ISSUES WITH FIBRIN CLOTS OR STRANGDS. THEY HAVE VERIFIED CENTRIFUGE OPERATION IS WITHIN SPEC. LOT#1011493".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367986, BATCH NO. 1011493. IT IS REPORTED CUSTOMER EXPERIENCED FIBRIN ISSUES. CUSTOMER IS EXPERIENCING ISSUES WITH 367986. THEY ARE WAITING OVER 30 MINUTES PRIOR TO SPINNING AND STILL HAVING ISSUES WITH FIBRIN CLOTS OR STRANGDS. THEY HAVE VERIFIED CENTRIFUGE OPERATION IS WITHIN SPEC. LOT#1011493".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633889 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 1011493 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1