BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 3.6MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 19925344 · Received August 6, 2024

    Report

    Report Number
    9617032-2024-01179
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903678366
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4: MEDICAL DEVICE LOT #: 4100840. D4: MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. H4: DEVICE MANUFACTURE DATE: 09-APR-2025. D4: MEDICAL DEVICE LOT #: 4022456. D4: MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2025. H4: DEVICE MANUFACTURE DATE: 22-JAN-2024. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MOLDING DEFECT WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MOLDING DEFECT 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 MOLDING DEFECT. 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 BD VACUTAINER® K3E 3.6MG PLUS BLOOD COLLECTION TUBES THAT AN UNSPECIFIED NUMBER OF TUBES CONTAIN PLASTIC PROTRUSIONS FROM INSIDE THE TUBE WALL. THIS INTERFERED WITH ASPIRATION OF THE SAMPLE BY LABORATORY ANALYZERS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265345 BD VACUTAINER® K3E 3.6MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H11 30382903678366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown