BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 10691962 · Received October 16, 2020

    Report

    Report Number
    1917413-2020-00955
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 23, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED 3 SAMPLES AND 2 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SPOT IN TUBES/ EMBEDDED FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, ALL CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR SPOT IN TUBES/ EMBEDDED FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367933) FROM LOT 0100288: SPOT IN TUBE X3."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAD FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED, "THE FOLLOWING ISSUE WAS FOUND IN TUBES (367933) FROM LOT 0100288: SPOT IN TUBE X3."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159153 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367983 0100288 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other