BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES

    MDR report key: 18974973 · Received March 25, 2024

    Report

    Report Number
    1917413-2024-00235
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678410
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVAL- YES . D9. RETURNED TO MANUFACTURER ON: 02-APR-2024. H.6. INVESTIGATION SUMMARY: BD HAD RECEIVED ONE SAMPLE IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367841, LOT NUMBER 3111796. VISUAL EXAMINATION OF THE SAMPLE WAS PERFORMED AND REVEALED IMPROPER ASSEMBLY CAUSING THE STOPPER TO NOT BE PLACED CORRECTLY IN THE HEMOGARD CLOSURE. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. 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. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G.4. PMA / 510(K)#: K213670 D.4. MEDICAL DEVICE TYPE: GIM E.4. INITIAL REPORTER FACILITY NAME: (B)(6)

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THE STOPPER IS DEFORMED AND DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES THE STOPPER IS DEFORMED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933 BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3111796 30382903678410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown