BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES

    MDR report key: 22022364 · Received May 14, 2025

    Report

    Report Number
    1024879-2025-00665
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903678199
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 19-MAY-2025. INVESTIGATION SUMMARY: BD RECEIVED 20 (5 PER BATCH NUMBER) CUSTOMER SAMPLES AND 8 CUSTOMER PHOTOS FOR INVESTIGATION. THE SAMPLES WERE SUBJECTED TO A VISUAL INSPECTION AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT NUMBERS WAS OBSERVED. ADDITIONALLY, BD REVIEWED EIGHT CUSTOMER PHOTOS, WHICH CONFIRMED THE PRESENCE OF ADDITIVE RUNDOWN DEFECTS. 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 LOTS 4094089, 4130027, 4184734 AND 4281529, FOR THE INDICATED FAILURE MODE: ADDITIVE ABNORMALITY. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 10 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 4 OF 4: IT WAS REPORTED WHILE USING BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES, 10 TUBES EXHIBITED ADDITIVE ABNORMALITY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882298 BD VACUTAINER® SERUM PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4184734 30382903678199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown