BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    MDR report key: 17015079 · Received May 26, 2023

    Report

    Report Number
    9617032-2023-00616
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 30, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 369032. LOT/BATCH #: 2040938. BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR HEMOLYSIS, UNABLE TO PIERCE STOPPER, AND STOPPER POP OFF WITH THE INCIDENT LOT WERE NOT OBSERVED. CUSTOMERS USED CENTRIFUGE SETTINGS ARE 3500G 5-6MIN, BD RECOMMENDATION FOR PROCESSING THE SAMPLES ARE 1300G 10 MIN. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION, 10 BY FUNCTIONAL DRAW TESTING WITH WATER, AND 8 CENTRIFUGED AT 1300G FOR 10 MINUTES, AND NO ISSUES WERE OBSERVED RELATING TO HEMOLYSIS, UNABLE TO PIERCE STOPPER, AND STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES HEMOLYSIS, UNABLE TO PIERCE STOPPER, AND STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    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 BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES HEMOLYSIS, STOPPER CREEP OUT AND LOOSE CLOSURE WERE OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING VACUTAINER TUBES ( CUSTOMER ) AND I HAD A MEETING AND SHE EXPLAINED TO ME AS MENTIONED A- OCCURRENCE OF HEMOLYSIS B- THE NEEDLE OF SYRINGE DOESN'T PENETRATE THE CAP OF THE TUBE, WHICH LEAD TO REMOVING THE CAP DURING THE PROCESS OF DRAWING THE SAMPLE EVERY TIME AND THIS PROBLEM IS ALSO IN THE EDTA TUBES ( CODE 368857).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES HEMOLYSIS, STOPPER CREEP OUT AND LOOSE CLOSURE WERE OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE USING VACUTAINER TUBES ( CUSTOMER ) AND I HAD A MEETING AND SHE EXPLAINED TO ME AS MENTIONED. A- OCCURRENCE OF HEMOLYSIS. B- THE NEEDLE OF SYRINGE DOESN'T PENETRATE THE CAP OF THE TUBE, WHICH LEAD TO REMOVING THE CAP DURING THE PROCESS OF DRAWING THE SAMPLE EVERY TIME AND THIS PROBLEM IS ALSO IN THE EDTA TUBES ( CODE (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670550 BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2040938

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown