BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 16777428 · Received April 20, 2023

    Report

    Report Number
    9617032-2023-00451
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 31, 2023
    Report Date
    April 12, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6. INVESTIGATION SUMMARY: BD RECEIVED 1 PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT SHOWING 3 CAPS ON THE TUBES WHICH ARE INCOMPLETELY MOULDED AND HAVE GAPS IN THEIR PLASTIC. ADDITIONALLY, 100 RETAINED SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED, AND NO ISSUES WERE OBSERVED RELATING TO DEFORMED SHIELD. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTO PROVIDED. BD WAS NOT ABLE TO IDENTIFY THE EXACT ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED FOR THE LOT 3002704. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. A QUALITY NOTIFICATION RELATED TO THE MOULDING WAS GENERATED FOR LOT NUMBER U10729337 AND, ALL DEFECTS HAVE BEEN REMOVED PER BD PROCEDURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITIONS 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 THE IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES HAD DEFORMED CAPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: FOLLOWING AN EXCHANGE WITH YOUR SALESMAN I AM SENDING YOU AN IMAGE OF THE DEFECT THAT WE ENCOUNTER ON SEVERAL TUBES RECEIVED, THIS DEFECT IS PRESENT ONLY ON THE BATCH THAT I AM SENDING YOU. ON AVERAGE (B)(4) TUBES ARE CONCERNED ON A TRAY OF (B)(4) TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745402 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 368861 3002704 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown