BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BLOOD TRANSFER DEVICE

    MDR report key: 20463731 · Received October 16, 2024

    Report

    Report Number
    2618282-2024-00150
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K222478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE LOT #: 4114185; D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027; D4. UNIQUE IDENTIFIER (UDI) #: (B)(4); H4. DEVICE MANUFACTURE DATE: 21-MAY-2024. D4. MEDICAL DEVICE LOT #: 4058222; D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027; D4. UNIQUE IDENTIFIER (UDI) #: (B)(4); H4. DEVICE MANUFACTURE DATE: 01-APR-2024. D4. MEDICAL DEVICE LOT #: 4081651; D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027; D4. UNIQUE IDENTIFIER (UDI) #: (B)(4); H4. DEVICE MANUFACTURE DATE: 06-MAY-2024. E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 12 RETENTION SAMPLES FROM BD INVENTORY OF EACH LOT WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED RELATING TO INSUFFICIENT BLOOD FLOW 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 MODE INSUFFICIENT BLOOD FLOW. 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 THE BD VACUTAINER BLOOD TRANSFER DEVICE THAT THERE WAS A POOR CONNECTION, WHICH CAUSED INSUFFICIENT BLOOD FLOW. THIS OCCURRED FOURTEEN (14) TIMES ACROSS THREE BATCHES OF DEVICES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322793 BD VACUTAINER BLOOD TRANSFER DEVICE BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown