BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 10417965 · Received August 17, 2020

    Report

    Report Number
    1710034-2020-00518
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673266
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT THREE (3) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE DEFECT OF DAMAGED (TUBING) AS STATED, WAS NOT CONFIRMED. INSTEAD, THE INVESTIGATION HAS CONFIRMED THE EXTENSION TUBING HAS ADHESIVE IN THE AREA BELOW THE LUER ADAPTER. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF DAMAGED THROUGH A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1172284. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FAILED TO CONTAIN BLOOD OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND THAT THE TUBING WAS PARTLY DAMAGED. BD IS REQUIRED TO REPLACE THE COMPLAINT PRODUCT AND SUBMIT A CLOSURE LETTER ABOUT THE CAUSE(S)."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET FAILED TO CONTAIN BLOOD OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND THAT THE TUBING WAS PARTLY DAMAGED. BD IS REQUIRED TO REPLACE THE COMPLAINT PRODUCT AND SUBMIT A CLOSURE LETTER ABOUT THE CAUSE(S)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876486 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367326 9088545 50382903673266

    Patients

    Seq Age Sex Outcome Treatment
    1 Other