BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ABBOTT TUBE K2 EDTA (K2E) PLASTIC COLLECTION TUBES

    MDR report key: 7705229 · Received July 19, 2018

    Report

    Report Number
    1917413-2018-03151
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INCORRECT DATE ON CERTIFICATION OF CONFORMANCE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR INCORRECT DATE ON CERTIFICATION OF CONFORMANCE WITH THE INCIDENT LOT WAS OBSERVED. BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. 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 · 0

    IT WAS REPORTED THAT THE EXPIRATION DATE ON THE BD¿ ABBOTT TUBE K2 EDTA (K2E) PLASTIC COLLECTION TUBES HAD ON THE CERTIFICATE OF CONFORMANCE FOR LOT 8099557 INDICATES ¿ 2019-06-03¿ AND THE EXPIRATION DATE ON THE LABEL INDICATES ¿2019-06-30.¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPIRATION DATE ON THE BD¿ ABBOTT TUBE K2 EDTA (K2E) PLASTIC COLLECTION TUBES HAD ON THE CERTIFICATE OF CONFORMANCE FOR LOT 8099557 INDICATES ¿ 2019-06-03¿ AND THE EXPIRATION DATE ON THE LABEL INDICATES ¿2019-06-30.¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPIRATION DATE ON THE BD¿ ABBOTT TUBE K2 EDTA (K2E) PLASTIC COLLECTION TUBES HAD ON THE CERTIFICATE OF CONFORMANCE FOR LOT 8099557 INDICATES ¿ 2019-06-03¿ AND THE EXPIRATION DATE ON THE LABEL INDICATES ¿2019-06-30.¿ THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544660 BD¿ ABBOTT TUBE K2 EDTA (K2E) PLASTIC COLLECTION TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 8099557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other