BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 15141756 · Received August 1, 2022

    Report

    Report Number
    1917413-2022-00447
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 18, 2022
    Report Date
    September 13, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2080614. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2022. H.4. DEVICE MANUFACTURE DATE: 05-APR-2022. D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9 RETURNED TO MANUFACTURER ON: 06-SEP-2022. H.6. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE 1 SAMPLE WAS INSPECTED WITH NO ISSUES BEING IDENTIFIED. THE HEMOGARD CLOSURE ASSEMBLY WAS CORRECTLY ATTACHED TO THE TUBE AND WAS NOT LOOSE. FUNCTIONAL TESTING PERFORMED ON THE SAMPLE TUBE AND REVEALED VERY LITTLE VACUUM; THIS IS LIKELY CAUSED BY THE CAP BEING REMOVED PRIOR TO BEING RETURNED. ADDITIONALLY, 100 RETENTION SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. ADDITIONALLY, 10 RETENTION SAMPLES WERE FUNCTIONALLY TESTED AND NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WERE OBSERVED AND, NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WAS COMPLETED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE SAMPLE PROVIDED; HOWEVER, THE FAILURE MODE COULD NOT BE DUPLICATED IN THE RETENTION SAMPLE TESTING. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "CAP IS FALLING OFF CAUSING SPILLAGE AND REDRAWS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE "CAP IS FALLING OFF CAUSING SPILLAGE AND REDRAWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457262 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 2080614 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown