BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11090767 · Received December 29, 2020

    Report

    Report Number
    1024879-2020-00963
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 3, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. BD WAS NOT ABLE TO IDENTIFIY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES WERE USED AFTER EXPIRATION DATE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. NO ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS PRODUCT EXPIRED 09/2020 AND THEY USED THEM UNTIL THE MIDDLE OF NOV 2020 BEFORE THEY NOTICED THE PRODUCT WAS EXPIRED. THEY DISCARDED PRODUCT ONCE THEY REALIZED IT WAS EXPIRED. THE LOT NUMBER IS 9274445 SPOKE WITH THE CUSTOMER, AND SHE STATED THAT THE SERUM FROM THE DONORS IS POOLED AND THEN TESTED FOR CHEMISTRY TESTS AND SYPHILIS, AND THAT THESE TESTS DID NOT PROVIDE IN ERRONEOUS RESULTS. I EXPLAINED THAT BD DOES NOT RECOMMEND USING EXPIRED TUBES, AND CANNOT SAY HOW THE RESULTS WOULD BE AFFECTED.

    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 THAT TUBES WERE USED AFTER EXPIRATION DATE WITH BD VACUTAINER(R) SST" BLOOD COLLECTION TUBES. NO ERRONEOUS RESULTS OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS PRODUCT EXPIRED 09/20200 AND THEY USED THEM UNTIL THE MIDDLE OF (B)(6) 2020 BEFORE THEY NOTICED THE PRODUCT WAS EXPIRED. THEY DISCARDED PRODUCT ONCE THEY REALIZED IT WAS EXPIRED. THE LOT NUMBER IS 9274445. SPOKE WITH THE CUSTOMER, AND SHE STATED THAT THE SERUM FROM THE DONORS IS POOLED AND THEN TESTED FOR CHEMISTRY TESTS AND SYPHILIS, AND THAT THESE TESTS DID NOT PROVIDE IN ERRONEOUS RESULTS. I EXPLAINED THAT BD DOES NOT RECOMMEND USING EXPIRED TUBES, AND CANNOT SAY HOW THE RESULTS WOULD BE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555314 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 9274445 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1