BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19007840 · Received March 29, 2024

    Report

    Report Number
    1710034-2024-00265
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 11, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903673247
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES: JKA. D2A: COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET. E.1: INITIAL REPORTER FACILITY NAME: (B)(6). H.6. INVESTIGATION SUMMARY: "MATERIAL #: 367324. LOT/BATCH #: 3032591. BD RECEIVED 1 SAMPLE AND 1 PHOTO FOR INVESTIGATION. THE SAMPLE AND PHOTO WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LEAKAGE WAS OBSERVED AS THE EXTENSION TUBING IS DAMAGED. THE EXTENSION TUBING WAS CAUGHT IN THE PACKAGING SEAL AND A LONGITUDINAL BREACH WAS CREATED IN THE TUBING WHEN THE UNIT PACKAGING WAS CUT. THE BREACH WOULD HAVE ALLOWED FLUID TO LEAK FROM THE EXTENSION TUBING. ADDITIONALLY, 50 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION, AND ANOTHER 12 BY FUNCTIONAL DRAW TESTING, AND THE ISSUE OF DAMAGED TUBING / LEAKAGE WAS NOT OBSERVED. 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 DAMAGED TUBING. 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 THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THERE WAS BLOOD LEAKAGE FROM THE WINGED NEEDLE DURING USE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2593097 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3032591 00382903673247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown