BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 20844274 · Received December 4, 2024

    Report

    Report Number
    1917413-2024-01142
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 11, 2024
    Report Date
    January 6, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678465
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 21-NOV-2024. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLES AND INVESTIGATED 3 PHOTOS FOR INVESTIGATION. THE CUSTOMER SAMPLE AND PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING PRINT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 100 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING PRINT 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 MISSING PRINT. 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 PRIOR TO USING BD VACUTAINER® EDTA 2K A TUBE WAS MISSING THE LABEL INFORMATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® EDTA 2K A TUBE WAS MISSING THE LABEL INFORMATION. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050555 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 4045118 30382903678465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown