BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 9172390 · Received October 9, 2019

    Report

    Report Number
    2618282-2019-00258
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659741
    PMA / PMN Number
    K991702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO CLOTTING AS ALL SAMPLES MET SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    MATERIAL NO. 365974, BATCH NO. 9193433 IT WAS REPORTED THAT THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) CLOTTED DURING USE. THIS OCCURRED ON 8 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN HAVING A LARGE AMOUNT OF CLOTTED CBC¿S IN THE LAV MICROTAINERS. WE CURRENTLY HAVE LOTS 9065638,9144756, AND 9193433. HAVE YOU BEEN HAVING ANY ISSUES? SOME OF THEM LOOK AS THOUGH THEY DON¿T HAVE ANY ADDITIVE IN THEM AT ALL."

    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

    MATERIAL NO. 365974, BATCH NO. 9193433. IT WAS REPORTED THAT THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) CLOTTED DURING USE. THIS OCCURRED ON 8 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN HAVING A LARGE AMOUNT OF CLOTTED CBC¿S IN THE LAV MICROTAINERS. WE CURRENTLY HAVE LOTS 9065638, 9144756, AND 9193433. HAVE YOU BEEN HAVING ANY ISSUES? SOME OF THEM LOOK AS THOUGH THEY DON¿T HAVE ANY ADDITIVE IN THEM AT ALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964637 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 9193433 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Other