BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ONE USE HOLDER

    MDR report key: 19727416 · Received July 11, 2024

    Report

    Report Number
    1917413-2024-00629
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 26, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903648158
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: N/A, THIS DEVICE DOES NOT EXPIRE. INVESTIGATION SUMMARY: "MATERIAL #: 364815. LOT/BATCH #: 3201342. BD RECEIVED 250 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH CONNECTED TO A BD NEEDLE, AND NO DEFECTS WERE OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED 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 MODES DISCOLORED, DIFFICULT TO INSERT TUBE, AND LOOSE CONNECTION FROM NEEDLE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. IT IS RECOMMENDED TO HOLD THE VACUTAINER TUBE IN PLACE UNTIL IT HAS COMPLETED THE REQUIRED DRAW VOLUME AND FLOW HAS CEASED. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® ONE USE HOLDERS, THE BLOOD COLLECTION TUBES ARE DIFFICULT TO INSERT, THEY SEPARATE FROM THE ACQUISITION DEVICE, AND THEY ARE TOO OPAQUE TO SEE THE BLOOD COLLECTION TUBE FILL VOLUME. NO IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315984 BD VACUTAINER® ONE USE HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3201342 50382903648158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown