BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER

    MDR report key: 17995588 · Received October 24, 2023

    Report

    Report Number
    2618282-2023-00089
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 10, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    00382903649020
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "MATERIAL #: 36490200. LOT/BATCH #: 3030769. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING CASE LABEL WAS 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 MISSING CASE LABEL. 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."

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER, THERE WERE MISSING LABELS ON TWO BOXES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 BX COULDN'T BE USED DUE TO MISSING LABELS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER, THERE WERE MISSING LABELS ON TWO BOXES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 BX COULDN'T BE USED DUE TO MISSING LABELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744237 BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 3030769 00382903649020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown