BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19279529 · Received May 9, 2024

    Report

    Report Number
    1024879-2024-00416
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 19, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679837
    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

    INVESTIGATION SUMMARY, MATERIAL #: 367983, LOT/BATCH #:3104151, 3153025, 3194568, 3250880, AND 3283886. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY FOR LOT NUMBERS 3104151, 3153025, 3194568, 3250880, AND 3283886 WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO COLOR VARIATION, LABEL FLAW, DEFECTIVE PRODUCT/COMPONENT AND FOREIGN MATTER AS ALL SAMPLES MET SPECIFICATIONS. IN ADDITION, 20 RETAIN SAMPLES WERE SUBJECTED TO A DRAW TEST FOR LOW OR NO DRAW FOR LOT NUMBERS 3104151(TESTED BEFORE EXPIRATION), 3194568, 3250880, AND 3283886 AND NO ISSUE FOUND RELATING TO UNDERFILL. HOWEVER, THE ISSUE OF UNDERFILL WAS OBSERVED IN LOT# 3153025 ON THE RETAINS TESTING (BATCH EXPIRED ON 05-31-2024). BATCH WAS TESTED PRIOR TO EXPIRATION DATE. 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 OF COLOR VARIATION, LABEL FLAW, DEFECTIVE PRODUCT/COMPONENT, FOREIGN MATTER AND UNDERFILL FOR 3104151, 3194568, 3250880, AND 3283886, BUT IT IS CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL FOR LOT NUMBER 3153025. 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

    E1: INITIAL REPORTER PHONE # :(B)(6) E1: INITIAL REPORTER FACILITY NAME: OBSTETRICS AND GYNECOLOGY HOSPITAL, ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#:3283886 D4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2024 H4. DEVICE MANUFACTURE DATE: (B)(6) 2023 D4. MEDICAL DEVICE LOT#:3194568 D4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2024 H4. DEVICE MANUFACTURE DATE: (B)(6) 2023 D4. MEDICAL DEVICE LOT#:3153025 D4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2024 H4. DEVICE MANUFACTURE DATE: (B)(6) 2023 D4. MEDICAL DEVICE LOT#:3104151 D4. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2024 H4. DEVICE MANUFACTURE DATE: (B)(6) 2023 H.3. 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

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER EXPERIENCED WARPED LABELS, INSUFFICIENT NEGATIVE PRESSURE, INCORRECT HEAD CAP COLOR, TWISTED HEAD CAP AND FOREIGN OBJECT IN THE CAP ON MULTIPLE BATCHES. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE CUSTOMER EXPERIENCED WARPED LABELS, INSUFFICIENT NEGATIVE PRESSURE, INCORRECT HEAD CAP COLOR, TWISTED HEAD CAP AND FOREIGN OBJECT IN THE CAP ON MULTIPLE BATCHES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489426 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3250880 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown