BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 17646899 · Received August 29, 2023

    Report

    Report Number
    1917413-2023-00843
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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

    H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE (1) SAMPLE AND FOUR (4) PHOTOS FOR INVESTIGATION. THE SAMPLE AND PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER (FM) WAS OBSERVED. A WHITE FM STRAND WAS OBSERVED ON THE TUBE. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF FM. BD WAS NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THE INDICATED FAILURE MODE. HOWEVER, THERE HAS BEEN INCREASED AWARENESS FOR CLEANLINESS AND REDUCTION OF FOREIGN MATTER IN THE PLANT. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION:  YES D9: RETURNED TO MANUFACTURER ON: 2023-09-06.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K CUSTOMER REPORTS THAT THERE WAS A WHITE FIBER-LIKE FOREIGN MATTER FOUND IN THE GAP BETWEEN THE TUBE AND THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS REPORT IS ABOUT FM. A WHITE FIBER-LIKE FOREIGN MATTER WAS FOUND IN THE GAP BETWEEN THE TUBE AND THE CAP.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K CUSTOMER REPORTS THAT THERE WAS A WHITE FIBER-LIKE FOREIGN MATTER FOUND IN THE GAP BETWEEN THE TUBE AND THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS REPORT IS ABOUT FM. A WHITE FIBER-LIKE FOREIGN MATTER WAS FOUND IN THE GAP BETWEEN THE TUBE AND THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086142 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2132076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown