BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES

    MDR report key: 16550400 · Received March 15, 2023

    Report

    Report Number
    9617032-2023-00256
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 22, 2023
    Report Date
    July 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER ADDRESS 1: (B)(6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 368274. LOT: 2123553 . BD RECEIVED 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. AN EVALUATION OF THE PHOTOGRAPHS INDICATED A BAG WITH TUBES AND THE ISSUE OF LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETAINED SAMPLES FROM THE BD INVENTORY, WERE FUNCTIONALLY TESTED AND THE ISSUE OF LEAKAGE OR STOPPER POP OFF WAS OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOGRAPHS PROVIDED HOWEVER THE ISSUE COULD NOT BE DUPLICATED WITH THE RETENTION SAMPLE TESTING ANALYSIS. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED ISSUE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBE THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE AND SAMPLE LEAKAGE. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "PRACTICE OF THIS ACCOUNT WAS NOT OPENED TUBE'S LID. USERS COLLECTED BLOOD BY INJECTED SYRINGE THROUGH SEPTUM OF OUR TUBES. WHEN THEY SENT THE TUBES TO LABORATORY, TECHNICIANS FOUND BLOOD WAS LEAKED A LOT THE LIDS OF BD EDTA (CAT. 368274) LOT NO. 2123553 LOOSE AND SLIPPED OUT OF THE TUBES. IN THIS LOT, THEY FOUND 9 TUBES THAT SHOWED THIS INCIDENCE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBE THERE WAS STOPPER CREEP OUT OR LOOSE CLOSURE AND SAMPLE LEAKAGE. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "PRACTICE OF THIS ACCOUNT WAS NOT OPENED TUBE'S LID. USERS COLLECTED BLOOD BY INJECTED SYRINGE THROUGH SEPTUM OF OUR TUBES. WHEN THEY SENT THE TUBES TO LABORATORY, TECHNICIANS FOUND BLOOD WAS LEAKED A LOT THE LIDS OF BD EDTA (CAT. 368274) LOT NO. 2123553 LOOSE AND SLIPPED OUT OF THE TUBES. IN THIS LOT, THEY FOUND 9 TUBES THAT SHOWED THIS INCIDENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768013 BD VACUTAINER® K2E PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2123553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown