BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 15018269 · Received July 14, 2022

    Report

    Report Number
    1024879-2022-00368
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    June 17, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903672900
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    MATERIAL #: 367290 LOT/BATCH #: 2033250 BD HAD NOT RECEIVED SAMPLES, BUT FOUR (4) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BROKEN HUB WAS OBSERVED. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUE OF BROKEN HUB 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 BROKEN HUB. 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 WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE CUSTOMER STATED THAT DEVICE BROKE APART AND SPRAYED BLOOD IN AN EMPLOYEES FACE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE DEVICE IT BROKE APART AND SPRAYED BLOOD IN AN EMPLOYEES FACE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER THE CUSTOMER STATED THAT DEVICE BROKE APART AND SPRAYED BLOOD IN AN EMPLOYEES FACE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE DEVICE IT BROKE APART AND SPRAYED BLOOD IN AN EMPLOYEES FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062354 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367290 2033250 50382903672900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention