BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE

    MDR report key: 20313259 · Received September 26, 2024

    Report

    Report Number
    2618282-2024-00135
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 31, 2024
    Manufacturer
    BD CARIBE LTD.
    Product Code
    GIM
    UDI-DI
    50382903666039
    PMA / PMN Number
    K230493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 366603; LOT/BATCH #: 4024091. IT IS IMPORTANT TO NOTE THAT USAGE OF THIS PRODUCT FOR PLATELET COUNT IS CONSIDERED AN OFF-LABEL USE. THE INTENDED USE IS LIMITED TO SAMPLE COLLECTION USED IN THE MEASUREMENT OF HEMOGLOBIN (HGB) & HEMATOCRIT (HCT), WHEN ANALYZED ON SYSMEX XN - SERIES¿ SYSTEMS. LIMITATION NOTES ARE INCLUDED IN THE IFU AND PRINTED ON THE TUBE UNIT LABEL. NEVERTHELESS, EIGHT (8) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO THE INDICATED FAILURE MODE. RETENTION SAMPLE TESTING REVEALED ALL SAMPLES MET THE PERFORMANCE SPECIFICATIONS OUTLINED IN THE STANDARD FOR SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO6710). ADDITIONALLY, BD PERFORMED A CLINICAL STUDY ON 67 RETURNED SAMPLES TO VERIFY THE DESIGN OF THE DEVICE MET ITS INTENDED USE. SEVEN (7) OF THE SIXTY-SEVEN (67) SAMPLES WERE FLAGGED FOR PLATELET CLUMPS (10.4%). NONE OF THESE SAMPLES SHOWED VISUAL EVIDENCE OF PLATELET CLUMPS UPON SMEAR REVIEW. THEREFORE, ALL SAMPLES TESTED MET SPECIFICATIONS. THE REPORTED CONDITION OF PLATELET CLUMPING COULD NOT BE CONFIRMED AS THE DEFECT COULD NOT BE REPLICATED AND THE USAGE OF THIS PRODUCT FOR PLATELET COUNT IS CONSIDERED AN OFF-LABEL USE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS PLATELET CLUMPING IN TWO SAMPLES. THE SAMPLES WERE RECOLLECTED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433867 BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE CAPILLARY BLOOD COLLECTION TUBE IVD GIM BD CARIBE LTD. 4024091 50382903666039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown