BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 12980685 · Received December 10, 2021

    Report

    Report Number
    1917413-2021-01052
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 16, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 367929. LOT: 1040981. BD RECEIVED 1 PHOTO FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE CUSTOMER'S INDICATED FAILURE MODE OF VARYING FILL LINE WAS OBSERVED HOWEVER, MEASUREMENTS OF THE VARYING FILL LINES COULD NOT BE COMPLETED AS SAMPLES WERE NOT RETURNED. ADDITIONALLY, 100 RETENTION SAMPLES FROM THE BD INVENTORY WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED WITH THE PRINTED FILL LINE. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTO PROVIDED; HOWEVER, COULD NOT BE DUPLICATED IN THE RETENTIONS. 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 THAT 10 BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES HAD INCORRECTLY PRINTED FILL LINES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ACCORDING TO THE CUSTOMER'S REPORT, THE POSITION OF THE FILL LINE VARIES AMONG 100 TUBES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874843 BD VACUTAINER® SODIUM FLUORIDE 3.0MG N2E 6.0 MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 1040981

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown