BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES

    MDR report key: 15204708 · Received August 10, 2022

    Report

    Report Number
    9617032-2022-00749
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD RECEIVED 1 PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. REVIEW OF THE PHOTOGRAPH INDICATED ONE CLOUDY OUTER TUBE. WHILST THIS MAY BE AESTHETICALLY DISPLEASING IT IS NOT UNDERSTOOD TO AFFECT THE EFFICIENCY OF THE TUBE. 100 RETAINED TUBES FROM THIS LOT NUMBER: 2032086 WERE VISUALLY INSPECTED. NO CLOUDY TUBES WERE FOUND. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE PHOTO PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS FOR THE LOT: 2032086 WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. SUB-ASSEMBLY: THE DEVICE HISTORY RECORDS FOR THE MOULDING LOTS: U4638396 AND U8030119 WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. QUALITY NOTIFICATION: 200996006 WAS GENERATED FOR THE MOULDING TUBES LOT NUMBER: U4623968 ; ALL PRODUCT WAS DISPOSITIONED: ALL COMPLAINED QUANTITY OF 62,499 TUBES WERE SCRAPPED. 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 TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN TUBE; BIOLOGICAL AND NONBIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE COLOR OF THE TUBE IS NOT TRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166693 BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363048 2032086 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown