BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 15869492 · Received November 28, 2022

    Report

    Report Number
    1917413-2022-00745
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 8, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    H6: INVESTIGATION SUMMARY: NO SAMPLES AND NO PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT CATALOG 367846, LOT NUMBER 2080646. THEREFORE, 90 RETENTION SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED WITH NO ISSUES BEING IDENTIFIED WITH THE STOPPERS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE INVESTIGATION COMPLETED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K IT WAS DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THIS EVENT AFFECTED 100 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER WAS HARD AND IT WAS MORE DIFFICULT THAN USUAL TO INSERT THE NON PATIENT NEEDLE INTO IT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K IT WAS DIFFICULT/UNABLE TO PIERCE THROUGH STOPPER. THIS EVENT AFFECTED 100 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE RUBBER STOPPER WAS HARD AND IT WAS MORE DIFFICULT THAN USUAL TO INSERT THE NON PATIENT NEEDLE INTO IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125092 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2080646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown