BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES

    MDR report key: 12294778 · Received August 9, 2021

    Report

    Report Number
    1917413-2021-00710
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 19, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678711
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-08-03. H6: INVESTIGATION SUMMARY BD RECEIVED ONE (1) SAMPLE FROM EACH LOT FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED. PUNCTURE MARKS IN THE STOPPER WERE VISUALLY OBSERVED PRIOR TO FUNCTIONAL TESTING. ADDITIONALLY, TEN (10) RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL 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 OF UNDERFILL EVEN THOUGH PUNCTURE MARKS WERE OBSERVED IN THE STOPPER PRIOR TO FUNCTIONAL TESTING. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER TUBE SEEMS TO BE LOSING PRESSURE. IT IS NOT FILLING UP THE TUBE COMPLETELY OR NOT AT ALL. NO SUCTION. " 07/22/2021 ADDITIONAL INFORMATION: "THIS HAS BEEN A RANDOM ISSUE FOR THE PAST MONTH OR SO. SOME DAYS THE TUBES WILL DRAW AND OTHERS THEY APPEAR TO HAVE NO VACUUM, OR DRAW VERY LITTLE-LESS THAT HALF THE TUBE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1014117, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, AND DEVICE MANUFACTURE DATE: 2021-01-14. MEDICAL DEVICE LOT #: 1098467, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, AND DEVICE MANUFACTURE DATE: 2021-04-08. 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SODIUM HEPARINN (NH) BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE VACUTAINER TUBE SEEMS TO BE LOSING PRESSURE. IT IS NOT FILLING UP THE TUBE COMPLETELY OR NOT AT ALL. NO SUCTION. " 07/22/2021 ADDITIONAL INFORMATION: "THIS HAS BEEN A RANDOM ISSUE FOR THE PAST MONTH OR SO. SOME DAYS THE TUBES WILL DRAW AND OTHERS THEY APPEAR TO HAVE NO VACUUM, OR DRAW VERY LITTLE-LESS THAT HALF THE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190136 BD VACUTAINER SODIUM HEPARINN (NH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367871 SEE H.10 50382903678711

    Patients

    Seq Age Sex Outcome Treatment
    1