BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES

    MDR report key: 17455574 · Received August 3, 2023

    Report

    Report Number
    9617032-2023-01040
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 27-SEP-2023. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368856. LOT/BATCH #: 3093251. BD RECEIVED FIVE (5) SAMPLES AND TWO (2) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH FIFTEEN (15) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. 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 UNDERFILL BASED ON PHOTOS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT THE TUBES DO NOT FILL COMPLETELY WITH BLOOD, VACUUM IS NOT SUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES DO NOT FILL COMPLETELY WITH BLOOD, IT SEEMS AS IF THE VACUUM IS NOT SUFFICIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT THE TUBES DO NOT FILL COMPLETELY WITH BLOOD, VACUUM IS NOT SUFFICIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES DO NOT FILL COMPLETELY WITH BLOOD, IT SEEMS AS IF THE VACUUM IS NOT SUFFICIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951142 BD VACUTAINER® K3E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3093251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown