BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 15718538 · Received November 2, 2022

    Report

    Report Number
    9617032-2022-01087
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    October 19, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: 365900. LOT NUMBER: 2112311. BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 100 RETENTION SAMPLES FROM THE BD INVENTORY WERE TAKEN AND VISUALLY INSPECTED, AND NO FOREIGN MATTER WAS FOUND. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE VISUAL CHECK OF RETAINED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, CUSTOMER REPORT IS THAT THERE ARE COLORED TINY LUMPS IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER'S VERBATIM REPORT IS THAT THERE ARE COLORED TINY LUMPS IN THE TUBE.¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, CUSTOMER REPORT IS THAT THERE ARE COLORED TINY LUMPS IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER'S VERBATIM REPORT IS THAT THERE ARE COLORED TINY LUMPS IN THE TUBE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124221 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2112311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown