BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 17990323 · Received October 23, 2023

    Report

    Report Number
    1024879-2023-00740
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 13, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3006821 D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023 H4. DEVICE MANUFACTURE DATE: 06-JAN-2023 D4. MEDICAL DEVICE LOT#: 3011599 D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023 H4. DEVICE MANUFACTURE DATE: 11-JAN-2023.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO CORING AS ALL SAMPLES MET SPECIFICATIONS. 10 RETAIN SAMPLES FROM LOT# 3006821 WERE SUBJECTED TO A DRAW TEST AND A VISUAL INSPECTION OF THE STOPPER POST DRAW. 0 OF 10 RETAIN SAMPLES FAILED. ADDITIONALLY, 10 RETAIN SAMPLES FROM LOT# 3011599 WERE SUBJECTED TO A DRAW TEST AND A VISUAL INSPECTION OF THE STOPPER POST DRAW. 0 OF 10 RETAIN SAMPLES FAILED. 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 CORING. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE RUBBER STOPPERS EMBRITTLED. THIS EVENT OCCURRED 2 TIMES, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BECAUSE THE CONVENTIONAL RUBBER STOPPERS EMBRITTLEMENT, WHICH LEADS TO THE OBSTRUCTION OF PROBE OF AUTOMATED CELL COUNTERS, RESULTING THE SAMPLE CONTAMINATION AND INSTRUMENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE RUBBER STOPPERS EMBRITTLED. THIS EVENT OCCURRED 2 TIMES, NO REPORT OF ADVERSE OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BECAUSE THE CONVENTIONAL RUBBER STOPPERS EMBRITTLEMENT, WHICH LEADS TO THE OBSTRUCTION OF PROBE OF AUTOMATED CELL COUNTERS, RESULTING THE SAMPLE CONTAMINATION AND INSTRUMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227037 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown