BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE

    MDR report key: 15166014 · Received August 4, 2022

    Report

    Report Number
    9617032-2022-00701
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 8, 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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: D.9 DEVICE AVAILABLE FOR EVAL? YES. RETURNED TO MANUFACTURER ON - 07/15/2022. H.6 INVESTIGATION SUMMARY BD RECEIVED 3 SAMPLES AND 3 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE ISSUE OF TUBE COLOR VARIATION (CLOUDY COLOR) WAS OBSERVED WITH THE TUBES SHOWING VARYING AMOUNTS OF CLOUDINESS. ADDITIONALLY, 100 RETENTION TUBES WERE EVALUATED AND WERE FOUND TO EXHIBIT NO EVIDENCE OF CLOUDINESS. WHILST THIS MAY BE AESTHETICALLY DISPLEASING IT IS NOT UNDERSTOOD TO AFFECT THE EFFICIENCY OF THE TUBE. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BASED ON THE SAMPLES AND PHOTOS PROVIDED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS FOR LOT 2032086 WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. QUALITY NOTIFICATION 200996006 WAS GENERATED FOR THE MOULDING TUBES AND ALL PRODUCT WAS DISPOSITIONED: ALL COMPLAINED QUANTITY OF 62,499 TUBES WERE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT AFFECTED 1000 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE COLOR OFF THE TUBE IS NOT TRANSPARENT."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT AFFECTED 1000 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE COLOR OFF THE TUBE IS NOT TRANSPARENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786963 BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363048 2032086 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown