BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 17484032 · Received August 8, 2023

    Report

    Report Number
    1024879-2023-00546
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678209
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367820. LOT/BATCH #: 3170988. BD RECEIVED 10 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER-MOISTURE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER-MOISTURE 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. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE FOREIGN MATTER-MOISTURE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES "CONDENSATION" FOREIGN MATTER WAS DISCOVERED IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS TUBES WITH CONDENSATION FOR CAT 367820 LOT 3170988.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD VACUTAINER® SERUM BLOOD COLLECTION TUBES "CONDENSATION" FOREIGN MATTER WAS DISCOVERED IN THE TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS TUBES WITH CONDENSATION FOR CAT 367820 LOT 3170988.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318932 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3170988 50382903678209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown