BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE

    MDR report key: 18927427 · Received March 18, 2024

    Report

    Report Number
    9617032-2024-00393
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    UDI-DI
    30382903602118
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 360211. LOT/BATCH #: 2243810 . BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS NOT OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTO ATTACHED. 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 FOREIGN MATTER. 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 THAT WHEN USING THE BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE, A SMALL BLACK PARTICLE APPEARED ON THE SYRINGE. ONE QUANTITY AFFECTED. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360847 BD VACUTAINER® PRECISIONGLIDE¿ MULTIPLE SAMPLE NEEDLE BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 2243810 30382903602118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown