BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA

    MDR report key: 8773869 · Received July 9, 2019

    Report

    Report Number
    1917413-2019-01729
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 21, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903637060
    PMA / PMN Number
    K093972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD ACKNOWLEDGES THAT THE CUSTOMER HAS HAD AN ISSUE WITH THE INCIDENT LOT. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. ADDITIONALLY RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING. THE SAMPLES WERE EVALUATED AND NO VISIBLE DEFECTS WERE DETECTED, FURTHERMORE PROCESS CAPABILITY DATA FOR THE ADDITIVE DISPENSE EQUIPMENT WERE REVIEWED AND WERE FOUND TO BE WITHIN ACCEPTABLE OPERATIONAL REQUIREMENTS. AS OF 09/11/2019, NO OTHER COMPLAINTS INVOLVING BATCHES 9004697 OR 9042626 HAVE BEEN RECEIVED REPORTING CLOTTING ISSUES. 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. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAMPLE FROM A 2-DAY OLD MALE PATIENT COLLECTED IN THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA CLOTTED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 SAMPLE FROM A (B)(6) MALE PATIENT COLLECTED IN THE BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA CLOTTED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 5 INCIDENTS ON NICU PATIENTS ON (B)(6) 2019. 1: (B)(6) FEMALE - LOT 9004697 2: (B)(6) MALE - LOT 9042626 3:(B)(6) MALE - LOT 9042626 4: (B)(6) MALE - LOT 9042626 5: (B)(6) MALE - LOT 9004697 6: UNKNOWN DATE, UNKNOWN PT IDENTIFIERS, LOTS 9004697, 9042626 WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565210 BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9042626 50382903637060

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other