BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19174569 · Received April 24, 2024

    Report

    Report Number
    1024879-2024-00368
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 18, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    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: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS OBSERVED. ADDITIONALLY, 29 RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF STOPPER POP OFF WAS OBSERVED ON LOT 3257993 ONLY. NO ISSUES WERE OBSERVED ON LOT 3201199. 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 STOPPER POP OFF FOR BOTH LOTS.. BD WAS NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE INDICATED FAILURE MODE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3201199 . D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H.4. DEVICE MANUFACTURE DATE: 01-AUG-2023. E.1. INITIAL REPORTER ADDR 1:(B)(6). H.3. 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 AFTER DRAWING BLOOD USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE TUBE CAPS WERE FALLING OFF DURING TRANSPORTATION, WHICH RESULTED IN BLOOD LEAKAGE AND BIOLOGICAL CONTAMINATION WITH BLOOD. THIS EVENT OCCURRED WITH AN UNSPECIFIED AMOUNT OF TUBES. SAMPLE RECOLLECTION OCCURRED. THERE WAS NO REPORT OF USER IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER DRAWING BLOOD USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE TUBE CAPS WERE FALLING OFF DURING TRANSPORTATION, WHICH RESULTED IN BLOOD LEAKAGE AND BIOLOGICAL CONTAMINATION WITH BLOOD. THIS EVENT OCCURRED WITH AN UNSPECIFIED AMOUNT OF TUBES. SAMPLE RECOLLECTION OCCURRED. THERE WAS NO REPORT OF USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070747 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3257993 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown