BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES

    MDR report key: 17515315 · Received August 11, 2023

    Report

    Report Number
    1917413-2023-00779
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 18, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678568
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE THOUSAND (1000) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EXAMINED, AND ALL SAMPLES CONTAINED ADDITIVE. ADDITIONALLY, TEN (10) SAMPLES WERE RANDOMLY SELECTED AND EVALUATED BY FUNCTIONAL TESTING. THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. TEN (10) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUES OF UNDERFILL AND MISSING ADDITIVE WERE 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES OF MISSING ADDITIVE AND UNDERFILL. 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. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION:  YES. D9: RETURNED TO MANUFACTURER ON: 08-SEPT-2023

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT TUBE IS WITHOUT VACUUM AND IS MISSING AN ANTICOAGULANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY CUSTOMER THAT TUBES WITHOUT VACUUM AND ANTICOAGULANT FOR CAT 367856 LOT 3074262. - CUSTOMER PROBLEM: CUSTOMER IS REPORTING THAT TUBES ARRIVED WITHOUT VACUUM AND AUTOCOAGULANT UNDER THE LOT 3074262. THEY ARE REQUESTING SHIPMENT OF NEW LOT 3111802. - STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: DOCUMENTED COMPLAINT, TRANSFERRED TO FOLLOW UP QUEUE FOR TRAINED ASSOCIATE TO ASSIST - NEXT STEPS (IF NECESSARY): PENDING FOR TRAINED ASSOCIATE TO ASSIST CUSTOMER IS REPORTING THAT TUBES ARRIVED WITHOUT VACUUM AND AUTOCOAGULANT UNDER THE LOT 3074262. THEY ARE REQUESTING SHIPMENT OF NEW LOT 3111802.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES CUSTOMER REPORTS THAT TUBE IS WITHOUT VACUUM AND IS MISSING AN ANTICOAGULANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY CUSTOMER THAT TUBES WITHOUT VACUUM AND ANTICOAGULANT FOR CAT 367856 LOT 3074262. CUSTOMER PROBLEM: CUSTOMER IS REPORTING THAT TUBES ARRIVED WITHOUT VACUUM AND AUTOCOAGULANT UNDER THE LOT 3074262. THEY ARE REQUESTING SHIPMENT OF NEW LOT 3111802. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: DOCUMENTED COMPLAINT, TRANSFERRED TO FOLLOW UP QUEUE FOR TRAINED ASSOCIATE TO ASSIST. NEXT STEPS (IF NECESSARY): PENDING FOR TRAINED ASSOCIATE TO ASSIST CUSTOMER IS REPORTING THAT TUBES ARRIVED WITHOUT VACUUM AND AUTOCOAGULANT UNDER THE LOT 3074262. THEY ARE REQUESTING SHIPMENT OF NEW LOT 3111802.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2176530 BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3074262 50382903678568

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown