BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES

    MDR report key: 11510028 · Received March 17, 2021

    Report

    Report Number
    9617032-2021-00244
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630474
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 2021-03-15 H6: INVESTIGATION SUMMARY BD RECEIVED 5 SAMPLES WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE EXPIRY DATE OF THE LOT NUMBER INVOLVED WAS 28TH FEBRUARY 2021. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE TUBES HAVE EXPIRED. 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. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES HEMOLYZED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HELLO, PLEASE FIND ENCLOSED THE MTV-21N-0090 DECLARATION OF MATERIAL VIGILANCE FOR ONE OF YOUR DEVICES: NAME : SODIUM CITRATE TUBE REFERENCE : (B)(4). LOT: 0230263 THE DEVICE IS AVAILABLE FOR EXPERTISE. ALL THE BLUE COAGULATION TUBES ARRIVED HEMOLYSED AT THE LABORATORY, DURING SEVERAL DAYS . CLINICAL CONSEQUENCES : DELAY IN TREATMENT, PATIENTS HAVE TO BE REPAIRED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDRESS; (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES HEMOLYZED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HELLO, PLEASE FIND ENCLOSED THE MTV-21N-0090 DECLARATION OF MATERIAL VIGILANCE FOR ONE OF YOUR DEVICES: NAME : SODIUM CITRATE TUBE REFERENCE : 363047, LOT: 0230263. THE DEVICE IS AVAILABLE FOR EXPERTISE. ALL THE BLUE COAGULATION TUBES ARRIVED HEMOLYSED AT THE LABORATORY, DURING SEVERAL DAYS . CLINICAL CONSEQUENCES : DELAY IN TREATMENT, PATIENTS HAVE TO BE REPAIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403982 BD VACUTAINER BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363047 0230263 50382903630474

    Patients

    Seq Age Sex Outcome Treatment
    1