BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE

    MDR report key: 20091506 · Received August 28, 2024

    Report

    Report Number
    2618282-2024-00117
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 24, 2024
    Report Date
    September 13, 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 30-MAY-2024. INVESTIGATION SUMMARY: MATERIAL #: 366603. LOT/BATCH #: 4024091. BD RECEIVED TEN (10) CUSTOMER RETURNED SAMPLES FOR INVESTIGATION VIA A RELATED COMPLAINT. THE TEN SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING FOR FACTORS RELATING TO THE INDICATED FAILURE MODE OF CLOTTING, AND NO ISSUES WERE OBSERVED. ADDITIONALLY, BD RECEIVED A CUSTOMER COMPLAINT RELATED TO PLATELET CLUMPING. 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 MODES. EIGHT (8) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO CLOTTING OR PLATELET CLUMPING. 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). BD REQUESTED ADDITIONAL RETURN SAMPLES TO FURTHER EVALUATE THE PERFORMANCE OF THE DEVICE THROUGH AN INTERNAL BD CLINICAL STUDY. ONE-HUNDRED AND FIFTY (150) CUSTOMER SAMPLES WERE RECEIVED FOR FURTHER EVALUATION. OF THOSE, 67 CUSTOMER SAMPLES WERE EVALUATED VIA A CLINICAL STUDY EVALUATION. THE STUDY DID NOT OBSERVE ANY SAMPLE CLOTTING ISSUES WHEN SAMPLES WERE COLLECTED ACCORDING TO THE PRODUCT IFU. NO MACROSCOPIC CLOTS WERE OBSERVED FOR ANY SUCCESSFUL COLLECTIONS, EITHER IMMEDIATELY AFTER COLLECTION OR AFTER ~24 HOURS OF REFRIGERATION. THE STUDY REVEALED ALL SAMPLES TESTED MET SPECIFICATION, AND THE RATE OF OBSERVED CLOTS WAS 0%. FURTHERMORE, BD PERFORMED A CLINICAL STUDY ON THE SAME 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. 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 CLOTTING OR PLATELET CLUMPING. NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED. 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 ONE SAMPLE EXHIBITING CLOTTING AND ONE SAMPLE EXHIBITING PLATELET CLUMPING. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE, THERE WAS ONE SAMPLE EXHIBITING CLOTTING AND ONE SAMPLE EXHIBITING PLATELET CLUMPING. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520307 BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE CAPILLARY BLOOD COLLECTION TUBE IVD, NO ADDITIVE GIM BD CARIBE LTD. 4024091 50382903666039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown