BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD¿ TUBE

    MDR report key: 8565598 · Received April 30, 2019

    Report

    Report Number
    2243072-2019-00818
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD MADE MULTIPLE ATTEMPTS TO REACH THE CUSTOMER IN ORDER TO GATHER MORE INFORMATION ON THE CATALOG AND LOT NUMBER; HOWEVER, BD HAD NOT RECEIVED A RESPONSE FROM THE CUSTOMER. A GOOD FAITH EFFORT HAS BEEN MADE AND THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER INVESTIGATION AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. AS BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE, PHOTO, CATALOG NUMBER, AND/OR LOT NUMBER FROM THE CUSTOMER FACILITY FOR EVALUATION, AN INVESTIGATION COULD NOT BE PERFORMED AS NO INFORMATION WAS AVAILABLE FOR REVIEW. AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 UNSPECIFIED BD¿ TUBE WAS USED AND GAVE ERRONEOUS RESULT OF ELEVATED HCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN IT WAS REPORTED THAT LAB RECEIVED ERRONEOUS RESULT OF ELEVATED HCT WHILE USING TUBE.. I HAD A LAB RESULT COME BACK WITH A 62.4 HCT, THE SAMPLE WAS REDRAWN AND THE RESULT WAS 35.4. THE TUBE IS A 4.0ML K2 EDTA 7.2MG. THE LABORATORY SUPERVISOR TOLD ME THAT IT WAS A BAD EDTA TUBE. WITH 15 YEARS OF EXPERIENCE IN A CLINIC LAB I HAVE NOT SEEN THIS NOR DO I THINK IT IS POSSIBLE. IF IT WAS POSSIBLE I WOULD THINK THE CUSTOMER WOULD CONTACT YOU AND IF THERE IS ACTUALLY AN ISSUE THIS WOULD BE REPORTED TO THE FDA? CAN YOU PROVIDE SOME GUIDANCE? CAN THIS HAPPEN WITH AN EDTA TUBE?

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBE WAS USED AND GAVE ERRONEOUS RESULT OF ELEVATED HCT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. IT WAS REPORTED THAT LAB RECEIVED ERRONEOUS RESULT OF ELEVATED HCT WHILE USING TUBE. I HAD A LAB RESULT COME BACK WITH A 62.4 HCT, THE SAMPLE WAS REDRAWN AND THE RESULT WAS 35.4. THE TUBE IS A 4.0ML K2 EDTA 7.2MG. THE LABORATORY SUPERVISOR TOLD ME THAT IT WAS A BAD EDTA TUBE. WITH 15 YEARS OF EXPERIENCE IN A CLINIC LAB I HAVE NOT SEEN THIS NOR DO I THINK IT IS POSSIBLE. IF IT WAS POSSIBLE I WOULD THINK THE CUSTOMER WOULD CONTACT YOU AND IF THERE IS ACTUALLY AN ISSUE THIS WOULD BE REPORTED TO THE FDA? CAN YOU PROVIDE SOME GUIDANCE? CAN THIS HAPPEN WITH AN EDTA TUBE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356703 UNSPECIFIED BD¿ TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention