BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 18695713 · Received February 13, 2024

    Report

    Report Number
    1024879-2024-00126
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 16, 2024
    Report Date
    June 4, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MIXED PRODUCT WITH THE INCIDENT LOT WAS NOT OBSERVED. ONE PHOTO SHOWS LOOSE TUBES AND THE OTHER PHOTO SHOWS AN OPENED SHELF PACK LABEL. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO MIXED PRODUCT AS ALL SAMPLES MET SPECIFICATIONS. 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 MIXED PRODUCT. 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

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE PACKAGE CONTAINED TWO DIFFERENT TYPES OF TUBES. THE LABEL STATED PRODUCT NUMBER 367986 AND LOT NUMBER 3215461. THE PACKAGE CONTAINED THE TUBES STATED ON THE LABEL, AS WELL AS TUBES WITH MATERIAL NUMBER 367977, LOT NUMBERS 2251860 AND 2129759. THE TUBES WERE NOT USED, AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE PACKAGE CONTAINED TWO DIFFERENT TYPES OF TUBES. THE LABEL STATED PRODUCT NUMBER 367986 AND LOT NUMBER 3215461. THE PACKAGE CONTAINED THE TUBES STATED ON THE LABEL, AS WELL AS TUBES WITH MATERIAL NUMBER 367977, LOT NUMBERS 2251860 AND 2129759. THE TUBES WERE NOT USED, AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806333 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3215461 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown