BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17033816 · Received May 31, 2023

    Report

    Report Number
    2243072-2023-00932
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    April 30, 2023
    Report Date
    May 17, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.6 INVESTIGATION SUMMARY: "MATERIAL #: 368774. LOT/BATCH #: 230201. BD RECEIVED 100 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT LOT 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 POOR BARRIER SEPARATION. 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." H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN THAT THERE WAS A MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUANTITY OF PRODUCT AFFECTED? 1. HOW LONG AFTER BLOOD COLLECTION ARE TUBES CENTRIFUGATED? MINIMUM 5 MIN CLOTTING TIME. WHAT IS THE STATED DRAW VOLUME OF THE TUBE? 5ML. HOW MUCH BLOOD IS THE TUBE DRAWING? 5 ML. DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? YES. WERE ANY ERRONEOUS RESULTS REPORTED TO HEALTHCARE PROVIDER? NO, TUBE WAS REJECTED FOR TESTING. ANY OTHER PATIENT IMPACT: NO. HOW MANY TUBES HAVE YOU SEEN THIS OCCUR WITH? 4. CUSTOMER PROBLEM: CUSTOMER REPORTS THAT THERE IS NO BARRIER FORMATION AFTER CENTRIFUGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296048 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 368774 230201 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown