BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 20945514 · Received December 16, 2024

    Report

    Report Number
    3003916417-2024-00290
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 21, 2024
    Report Date
    February 26, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 11-DEC-2024. INVESTIGATION SUMMARY BD RECEIVED 154 CUSTOMER RETURN SAMPLE TUBES FROM LOT 4031209, 1 RETURN SAMPLE FROM LOT 4088557, AND NO RETURN SAMPLES FROM LOT 3303929. THE SAMPLES WERE VISUALLY INSPECTED AND GEL AIR BUBBLES WAS OBSERVED. ADDITIONALLY, 200 RETENTION SAMPLES FROM BD INVENTORY FOR LOT 3303929 WERE VISUALLY INSPECTED AND NO GEL AIR BUBBLES WERE OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL AIR BUBBLES FOR LOT #'S 4031209 AND 4088557 BASED ON THE RETURNED SAMPLES. LOT # 3303929 WAS UNABLE TO BE CONFIRMED FOR GEL AIR BUBBLES BASED ON THE RETENTION SAMPLE TESTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1: INITIAL REPORTER PHONE #: (B)(6). 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 · 0

    REPORT 2 OF 3: IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 1 TUBE HAD GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    REPORT 2 OF 3: IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, 1 TUBE HAD GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376582 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON IND. CIRURGICAS LTDA 4088557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown