BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 9403510 · Received December 3, 2019

    Report

    Report Number
    2243072-2019-02701
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER DID NOT PROVIDE BD PAS WITH PRODUCT CATALOG NUMBER OR LOT NUMBER INFORMATION, WHEN REQUESTED. AFTER 3-FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BD PAS HAS CLOSED THIS CUSTOMER COMPLAINT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE PRODUCED INCONSISTENT "TROPONIN" VALUES AFTER USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TROPONIN VALUES WERE INCONSISTENT WITH GREEN LITHIUM/SODIUM TUBES AND IT REMAINS UNKNOWN IF THIS WAS DUE TO THE INSTRUMENT OR TUBE."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD VACUTAINER® LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBE PRODUCED INCONSISTENT "TROPONIN" VALUES AFTER USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TROPONIN VALUES WERE INCONSISTENT WITH GREEN LITHIUM/SODIUM TUBES AND IT REMAINS UNKNOWN IF THIS WAS DUE TO THE INSTRUMENT OR TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201664 UNSPECIFIED BD VACUTAINER® LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other