BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 17295039 · Received July 10, 2023

    Report

    Report Number
    1024879-2023-00456
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 20, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS WAS OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED. 1 OUT OF 30 FAILED FOR AN ADDITIVE ABNORMALITY. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JUNE 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 HEMOLYSIS BASED ON THE PHOTO PROVIDED. THIS COMPLAINT WAS CONFIRMED FOR ADDITIVE ABNORMALITY BASED ON THE RETENTION SAMPLE TESTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR HEMOLYSIS.

    Additional Manufacturer Narrative · 0

    H.3. 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 THAT WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEMOLYSED SAMPLES OBSERVED FOR SKU 367815 RED TOP SERUM TUBE, LOT NUMBER: 2181513 FROM DIFFERENT CLINICS. CLINICS WERE INFORMED NOT TO USE THE TUBES ISSUED BY US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEMOLYSED SAMPLES OBSERVED FOR SKU 367815 RED TOP SERUM TUBE, LOT NUMBER: 2181513 FROM DIFFERENT CLINICS. CLINICS WERE INFORMED NOT TO USE THE TUBES ISSUED BY US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148380 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367815 2181513 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown