BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 18990450 · Received March 28, 2024

    Report

    Report Number
    2243072-2024-00454
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 368774. LOT/BATCH #: 230104. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED, AND THEY SHOW THE TUBE LABEL CONFIRMING THE LOT NUMBER. ADDITIONALLY, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, CHECKING THROMBIN STRENGTH, AND NO ISSUES WERE OBSERVED RELATING TO ERRONEOUS RESULTS AS ALL SAMPLES MET SPECIFICATIONS. FUNCTIONAL TESTING OF RETENTION SAMPLES FOR TROPONIN I COULD NOT TAKE PLACE AS LOT NUMBER 230104 IS EXPIRED. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SEKISUI. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, THE INITIAL SAMPLE PRODUCED ERRONEOUS RESULTS FOR TROPONIN I. THE PATIENT WAS TRANSFERRED TO THE ICU AND TREATED ACCORDING TO ERRONEOUS RESULTS. TREATMENT WAS DISCONTINUED AFTER REPEAT RESULTS WERE RECEIVED. NO MAJOR PATIENT IMPACT WAS REPORTED AS A RESULT OF TREATMENT CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN, THE INITIAL SAMPLE PRODUCED ERRONEOUS RESULTS FOR TROPONIN I. THE PATIENT WAS TRANSFERRED TO THE ICU AND TREATED ACCORDING TO ERRONEOUS RESULTS. TREATMENT WAS DISCONTINUED AFTER REPEAT RESULTS WERE RECEIVED. NO MAJOR PATIENT IMPACT WAS REPORTED AS A RESULT OF TREATMENT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724491 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 230104 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other