BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG

    MDR report key: 12362742 · Received August 24, 2021

    Report

    Report Number
    1917413-2021-00780
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 4, 2021
    Report Date
    November 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903637060
    PMA / PMN Number
    K093972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-08-30. H6: INVESTIGATION SUMMARY: BD RECEIVED 5 SAMPLES FOR INVESTIGATION (2 FROM LOT 1040047 AND 1 FROM LOTS 1040046, 0230171, AND 1075522). DUE TO THE LIMITED QUANTITY RECEIVED FOR EACH LOT, CLINICAL TESTING WAS PERFORMED ON RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE RETENTION SAMPLES WERE EVALUATED AND NO ISSUES RELATING TO CLOTTING WERE OBSERVED. VISUAL EVALUATION: 50 RETENTIONS FROM EACH LOT WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED. CLINICAL EVALUATION: BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOTTING) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL SAMPLES (RETAINS AND CONTROLS) DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. LABORATORY ANALYSIS OF SAMPLES INDICATED THAT THESE TUBES PERFORMED AS EXPECTED. 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG, THE DEVICE EXPERIENCED CLOTTING / MICRO-CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ED & NICU NOTED THIS. FIRST. LAB CONFIRMED INCREASE SPECIMENS CLOTTING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1040046. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 0205660. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2020-07-23. MEDICAL DEVICE LOT #: 0230171. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2020-08-17. MEDICAL DEVICE LOT #: 1075522. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-03-16. MEDICAL DEVICE LOT #: 1075524. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. DEVICE MANUFACTURE DATE: 2021-03-16. MEDICAL DEVICE LOT #: 1040047. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-02-09. 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 WHEN USING THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG, THE DEVICE EXPERIENCED CLOTTING / MICRO-CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ED & NICU NOTED THIS. FIRST. LAB CONFIRMED INCREASE SPECIMENS CLOTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258160 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA 1.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363706 SEE H.10. 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown