BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 7579823 · Received June 7, 2018

    Report

    Report Number
    1917413-2018-02704
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    October 21, 2015
    Report Date
    June 1, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678612
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5120676; MEDICAL DEVICE EXPIRATION DATE: 2016-09-30; DEVICE MANUFACTURE DATE: 2015-04-30; MEDICAL DEVICE LOT #: 5154719; MEDICAL DEVICE EXPIRATION DATE: 2016-10-31; DEVICE MANUFACTURE DATE: 2015-06-03; MEDICAL DEVICE LOT #: 5064889; MEDICAL DEVICE EXPIRATION DATE: 2016-07-31; DEVICE MANUFACTURE DATE: 2015-03-05. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT NUMBER AND NO ISSUES WERE IDENTIFIED. THE LOT HAD EXPIRED AS OF THE DATE OF EVALUATION; THEREFORE, NO FURTHER TESTING WILL BE CONDUCTED AT THIS TIME. INVESTIGATION CONCLUSION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT NUMBER AND NO ISSUES WERE IDENTIFIED. THE LOT HAD EXPIRED AS OF THE DATE OF EVALUATION; THEREFORE, NO FURTHER TESTING WILL BE CONDUCTED AT THIS TIME. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES HAD CLOTTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423107 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5154720 50382903678612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other