BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 20325080 · Received September 27, 2024

    Report

    Report Number
    9617032-2024-01557
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    UDI-DI
    30382903602101
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "MATERIAL #: 360210; LOT/BATCH #: 4003277. BD RECEIVED 600 SAMPLES FOR INVESTIGATION. TEN (10) OF THE SAMPLES WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE INDICATED FAILURE MODE FOR CLOGGED CANNULA WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 CLOGGED CANNULA. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLES, A PROPER BLOOD FLOW COULD NOT BE ESTABLISHED. THE DEVICES APPEARED TO BE CLOGGED. THIS OCCURRED WITH TWO (2) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684276 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 4003277 30382903602101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown