BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 16428108 · Received February 23, 2023

    Report

    Report Number
    1024879-2023-00109
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2173181. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30 DEVICE MANUFACTURE DATE: (B)(6) 2022. MEDICAL DEVICE LOT #: 2209924 MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 DEVICE MANUFACTURE DATE: (B)(6) 2022

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG NUMBER: 367988. BATCH NUMBER: 2173181, 2209924. BD HAD NOT RECEIVED SAMPLES, BUT 7 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER (FM) WITH THE INCIDENT LOT WAS NOT OBSERVED. PHOTOS PROVIDED WERE FROM ALIQUOTED SAMPLES AND DID NOT SHOW THE BD SST TUBE. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED FOR FM. NO ISSUES WERE OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: G.5 DATE RECEIVED BY MANUFACTURER : 2023-02-09.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CUSTOMER FOUND DEBRIS IN SERUM AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT TUBES HAD DEBRIS IN SERUM AFTER CENTRIFUGATION. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES TUBES CLOTTED AT RT FOR 45-70 MINUTES AND CENTRIFUGED FOR 15 MINUTES AT 1500 RCF."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CUSTOMER FOUND DEBRIS IN SERUM AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT TUBES HAD DEBRIS IN SERUM AFTER CENTRIFUGATION. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATES TUBES CLOTTED AT RT FOR 45-70 MINUTES AND CENTRIFUGED FOR 15 MINUTES AT 1500 RCF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576881 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 2209924 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown