BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER SST

    MDR report key: 10066174 · Received May 18, 2020

    Report

    Report Number
    2243072-2020-00784
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 28, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903659673
    PMA / PMN Number
    K991702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION D.4. MEDICAL DEVICE LOT #: 7130825 D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2018 H.4. DEVICE MANUFACTURE DATE: 5/10/2017 H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. THE CUSTOMER PROVIDED A LOT NUMBER THAT WAS IN USE AT THE TIME OF THE INCIDENT. THE CUSTOMER CANNOT CONFIRM THE SPECIFIC LOT USED. SINCE A SPECIFIC LOT WAS NOT PROVIDED, THE INVESTIGATOR DID EVALUATE THE LOT NUMBER THAT WAS PROVIDED AND IN USE AT THE TIME OF THE INCIDENT. RETAIN SAMPLE EVALUATION: EVALUATION OF RETENTION SAMPLES COULD NOT BE PERFORMED AS THE INCIDENT LOT HAS BEEN EXPIRED SINCE (B)(6) 2018. PER COMPLAINT HISTORY CHECK THIS IS THE FIRST COMPLAINT REPORTED FOR THE SAME DEFECT/CONDITION FOR LOT 7130825. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR COMPLAINTS RECEIVED FOR HIGH SODIUM VALUES FOR MATERIAL 365967 IN 2017. ONE COMPLAINT WAS FOUND TO HAVE BEEN REPORTED BY AN INSTRUMENT MANUFACTURER WORKING WITH A CHILDREN¿S HOSPITAL WITH NO LOT NUMBER REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR LOT 7130825. ALL IN-PROCESS AND FINAL INSPECTIONS WERE IN COMPLIANCE WITH REQUIREMENTS. ONE BREAKDOWN MAINTENANCE ORDERS WAS GENERATED DURING THE RUN. ONE OF THE ADDITIVE DISPENSE STATION PUMPS WAS REPLACED. THE MACHINE INTERVENTION DID NOT AFFECT PRODUCT QUALITY. EVALUATION OF LABORATORY INSTRUMENTATION REGARDING REPRODUCIBILITY/REPEATABILITY MAY BE OF VALUE. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. BASED ON THE LIMITED INFORMATION PROVIDED FOR THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE ERRONEOUS SODIUM VALUE RESULTS WITH A BD MICROTAINER® SST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED ISSUES WITH SODIUM VALUES COUPLE OF YEARS AGO. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. ADDITIONALLY, ON 2020-(B)(6)THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CANNOT CONFIRM THE SPECIFIC LOTS OF THE TUBES THAT YIELDED ERRONEOUS RESULTS. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. WILL BE CREATING 2 ADDITIONAL COMPLAINTS FOR THE PRODUCT NUMBERS GIVEN IN CUSTOMERS RESPONSE, AS WELL AS RELATING THEM.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. ]MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ERRONEOUS SODIUM VALUE RESULTS WITH A BD MICROTAINER® SST¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 3 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED ISSUES WITH SODIUM VALUES COUPLE OF YEARS AGO. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. ADDITIONALLY, ON 2020-04-28 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CANNOT CONFIRM THE SPECIFIC LOTS OF THE TUBES THAT YIELDED ERRONEOUS RESULTS. BASIC CHEM PANELS WERE RUN ¿ ERRONEOUS NA RESULTS WERE NOTED APPROXIMATELY 1/MONTH FOR A SERIES OF MONTHS DURING THIS TIME. WILL BE CREATING 2 ADDITIONAL COMPLAINTS FOR THE PRODUCT NUMBERS GIVEN IN CUSTOMERS RESPONSE, AS WELL AS RELATING THEM.89

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532041 BD MICROTAINER SST BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 365967 7130825 50382903659673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other