BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15413508 · Received September 13, 2022

    Report

    Report Number
    9617032-2022-00864
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 17, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 369032, LOT: 2040938. BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, (B)(4) RETAINED SAMPLES FROM THE BD INVENTORY WERE FUNCTIONALLY TESTED AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED AS ALL TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES TEST RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES, THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I HAVE A COMPLAINT REGARDING BD VACUTAINER PARTIC TUBES. SILICE CAP ROUGE, REFERENCES (B)(4), LOTS 2040938/ 1350459. REPEATED INCIDENTS OCCURRED IN THE PNEUMOLOGY CONSULTATION DEPARTMENT: THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES, THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I HAVE A COMPLAINT REGARDING BD VACUTAINER PARTIC TUBES. SILICE CAP ROUGE, REFERENCES 369032/ 367819, LOTS 2040938/ 1350459. REPEATED INCIDENTS OCCURRED IN THE PNEUMOLOGY CONSULTATION DEPARTMENT: THE TUBES DO NOT FILL CORRECTLY DURING SAMPLING, SEVERAL BATCHES BEING CONCERNED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534986 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 NA Unknown