BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 20984697 · Received December 19, 2024

    Report

    Report Number
    1024879-2024-01321
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 6, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 23-JAN-2025. THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 138 TUBES CONTAINED ABNORMALLY APPEARING ADDITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES AND 8 CUSTOMER PHOTOS (4 OF 8 CUSTOMER PHOTOS WERE PERTAINING TO BATCH NUMBER 4024121) FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WAS OBSERVED. ADDITIONALLY, 10 CUSTOMER SAMPLES WERE SUBJECTED TO A VISUAL INSPECTION AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT 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 ADDITIVE ABNORMALITY. 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

    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

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, 138 TUBES CONTAINED ABNORMALLY APPEARING ADDITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT AN UNSPECIFIED NUMBER OF TUBES CONTAINED ABNORMALLY APPEARING ADDITIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203494 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4024121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown