BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 17935952 · Received October 13, 2023

    Report

    Report Number
    1024879-2023-00704
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 18, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3067281. D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024. H4. DEVICE MANUFACTURE DATE: 08-MAR-2023. D4. MEDICAL DEVICE LOT #: 3088829. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024. H4. DEVICE MANUFACTURE DATE: 29-MAR-2023. D4. MEDICAL DEVICE LOT #: 3011610. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2024. H4. DEVICE MANUFACTURE DATE: 11-JAN-2023. E1. INITIAL REPORTER FACILITY NAME: THE FIRST AFFILIATED HOSPITAL OF SUN YAT-SEN UNIVERSITY H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOURTEEN CUSTOMER SAMPLES (6 FOR LOT# 3088829 AND 8 FOR LOT# 3067281) AND FIVE CUSTOMER PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS. NO CUSTOMER RETURN SAMPLES WERE RECEIVED FOR LOT 3011610 FOR THE UNDERFILL COMPLAINT. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER PHOTOS, GEL AIR BUBBLES, FOREIGN MATTER (FM), AND LABEL LIFT (OTHER WOULD BE CONSIDERED LABEL LIFT) CAN BE SEEN IN THE PHOTOS. 8 CUSTOMER SAMPLES (3 RECEIVED FOR GEL AIR BUBBLES AND 5 RECEIVED FOR FM)FROM LOT# 3067281 WERE SUBJECTED TO VISUAL INSPECTION FOR GEL AIR BUBBLES AND FM. 5 OF 8 CUSTOMER SAMPLES FAILED FOR FM. 3 OF 8 CUSTOMER SAMPLES FAILED FOR GEL AIR BUBBLES. 6 CUSTOMER SAMPLES (2 RECEIVED FOR LABEL LIFT AND 4 RECEIVED FOR FM) FROM LOT# 3088829 WERE SUBJECTED TO VISUAL INSPECTION FOR LABEL LIFT AND FM. 4 OF 6 CUSTOMER SAMPLES FAILED FOR FM. 2 OF 6 CUSTOMER SAMPLES FAILED FOR LABEL LIFT. ADDITIONALLY, 30 RETAIN SAMPLES FROM LOT# 3067281 WERE SUBJECTED TO A VISUAL INSPECTION FOR GEL AIR BUBBLES AND FM. 0 OF 30 SAMPLES FAILED. ADDITIONALLY, 30 RETAIN SAMPLES FROM LOT# 3088829 WERE SUBJECTED TO A VISUAL INSPECTION FOR GEL AIR BUBBLES, LABEL LIFT, AND FM. 0 OF 30 SAMPLES FAILED. IN ADDITION, 20 RETAIN SAMPLES FROM LOT 3011610 WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW. ALL TUBES WERE WITHIN SPECIFICATION. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED FOR GEL AIR BUBBLES. 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 GEL AIR BUBBLES, FM, AND LABEL LIFT. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED FOR UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AND DURING USE WITH 80 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE AIR BUBBLES, FOREIGN MATTER IN THE TUBE, AND INCORRECT FILL VOLUME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THERE ARE BUBBLES IN THE PRODUCT UNDER THIS ITEM NUMBER, FOREIGN OBJECTS IN THE SEPARATION ADHESIVE, AND INSUFFICIENT NEGATIVE PRESSURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AND DURING USE WITH 80 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE AIR BUBBLES, FOREIGN MATTER IN THE TUBE, AND INCORRECT FILL VOLUME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THERE ARE BUBBLES IN THE PRODUCT UNDER THIS ITEM NUMBER, FOREIGN OBJECTS IN THE SEPARATION ADHESIVE, AND INSUFFICIENT NEGATIVE PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748887 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H10 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown