BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    MDR report key: 17671401 · Received September 1, 2023

    Report

    Report Number
    1917413-2023-00862
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 15, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JCF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MATERIAL #: 362780. LOT/BATCH #: 2341889, 3142380, 3024227, 3046964, 3046965, AND 3142380. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 59 RETENTION SAMPLES OF THE INCIDENT LOTS WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR BARRIER SEPARATION OR POOR PLASMA WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY WERE NOT UNDER STATISTICAL CONTROL FOR THE MONTH OF AUGUST 2023, THEREFORE ADDITIONAL CLINICAL TESTING WAS REQUIRED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODES (POOR BARRIER SEPARATION, POOR PLASMA) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETENTION AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE POOR BARRIER SEPARATION OR POOR PLASMA. 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2341889; D4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31; H4. DEVICE MANUFACTURE DATE: 2022-12-07. D4. MEDICAL DEVICE LOT #: 3024227; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31; H4. DEVICE MANUFACTURE DATE: 2023-01-24. D4. MEDICAL DEVICE LOT #: 3046964; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29; H4. DEVICE MANUFACTURE DATE: 2023-02-15. D4. MEDICAL DEVICE LOT #: 3046965; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29; H4. DEVICE MANUFACTURE DATE: 2023-02-15. D4. MEDICAL DEVICE LOT #: 3142380; D4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31; H4. DEVICE MANUFACTURE DATE: 2023-05-22. 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 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML THAT THERE WAS POOR BARRIER SEPARATION OF SAMPLE/ INSUFFICIENT ADDITIVE QUANTITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDPACE IS COLLECTING BLOOD SAMPLES FROM PATIENTS AND CONTROLS. IN EUROPE THEY ENCOUNTER ISSUES WITH RED BLOOD CELL CONTAMINATION AND SLANTED GEL BARRIERS. THIS IS NOT RELATED TO A SPECIFIC PATIENT GROUP AS IT CAN BE SEEN IN HEALTHY CONTROLS AS WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML THAT THERE WAS POOR BARRIER SEPARATION OF SAMPLE/ INSUFFICIENT ADDITIVE QUANTITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MEDPACE IS COLLECTING BLOOD SAMPLES FROM PATIENTS AND CONTROLS. IN EUROPE THEY ENCOUNTER ISSUES WITH RED BLOOD CELL CONTAMINATION AND SLANTED GEL BARRIERS. THIS IS NOT RELATED TO A SPECIFIC PATIENT GROUP AS IT CAN BE SEEN IN HEALTHY CONTROLS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603953 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE JCF BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown