BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM

    MDR report key: 22240429 · Received June 17, 2025

    Report

    Report Number
    1024879-2025-00854
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    April 25, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903678144
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS FOR INVESTIGATION. BOTH PHOTOS SHOWED MULTIPLE TUBES WITH RED RINGS AROUND THE RIMS. ADDITIONALLY, 30 RETAINED SAMPLES FOR LOT NUMBER 4222903 WERE VISUALLY INSPECTED FOR ADDITIVE ABNORMALITY. ADDITIVE ABNORMALITY WAS OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 4222903, FOR THE INDICATED FAILURE MODES: RED CELL HANG UP AND RED CELL RING BASED ON CUSTOMER PHOTO. THIS COMPLAINT HAS BEEN CONFIRMED FOR ADDITIVE ABNORMALITY BASED ON THE RETAIN TESTING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED RED CELL HANG UP AND RED CELL RINGS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM, AN UNSPECIFIED NUMBER OF TUBES EXHIBITED RED CELL HANG UP AND RED CELL RINGS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435048 BD VACUTAINER® SERUM BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4222903 30382903678144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown