BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19169698 · Received April 23, 2024

    Report

    Report Number
    1024879-2024-00359
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 27, 2024
    Report Date
    July 1, 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

    E1. INITIAL REPORTER PHONE #: (B)(6) HOSPITAL. 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

    INVESTIGATION SUMMARY. "MATERIAL #: 367983. LOT/BATCH #: 3250882. BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER AND GEL AIR BUBBLES WERE OBSERVED. HOWEVER, GEL SMEARING WAS NOT SEEN. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER, GEL AIR BUBBLES, AND GEL SMEARING WERE NOT OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 OF FOREIGN MATTER AND GEL AIR BUBBLES AND UNCONFIRMED FOR GEL SMEARING. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE 17 TUBES WITH AIR BUBBLES IN THE GEL, 27 TUBES WITH GEL HANGING ON THE TUBE WALL, AND 2 TUBES WITH FOREIGN MATTER. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE 17 TUBES WITH AIR BUBBLES IN THE GEL, 27 TUBES WITH GEL HANGING ON THE TUBE WALL, AND 2 TUBES WITH FOREIGN MATTER. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273273 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3250882 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown