BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 8884572 · Received August 12, 2019

    Report

    Report Number
    2618282-2019-00238
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659741
    PMA / PMN Number
    K991702
    Removal / Correction Number
    PAS-19-1526
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS COMPLAINT IS ASSOCIATED TO FIELD ACTION # 2243072-05/09/2019-007-R. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND IT WAS FOUND THAT SEVERAL SAMPLES DID NOT HAVE VISIBLE ADDITIVE WITHIN THE TUBE RESERVOIR, CONTRIBUTING TO THE CUSTOMER'S INDICATED FAILURE MODE OF CLOTTING. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, SAMPLES WERE CONFIRMED TO HAVE REDUCED OR NO ADDITIVE WITHIN THE TUBE RESERVOIR. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#896640 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CLOTTING OCCURRED WITH BD MICROTAINER® TUBES WITH K2E (K2EDTA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM WRITING TO INFORM YOU OF A PROBLEM THAT I EXPERIENCED WITH A LOT OF BD MICROTAINER K2EDTA. IN THREE DAYS I HAD MULTIPLE PATIENT'S SAMPLES CLOT COMPLETELY SOLID. WE HAVE ALWAYS USED YOUR MICROTAINERS AND HAVE NEVER HAD A ISSUE IN THE PAST. ALL OF THE SAMPLES WERE EASILY OBTAINED AND WERE WELL MIXED.AFTER THE FIRST SAMPLE, I WAS VERY CONSCIOUS OF HOW WELL I WAS MIXING THE SAMPLES TO AVOID ANOTHER REDRAW. ALL OF THE TUBES WERE FROM THE SAME LOT OF K2EDTA MICROTAINERS : 9017593 EXP 6/30/2020. WE HAVE REMOVED ALL OF THIS LOT OF TUBES." 1 OF 2 COMPLAINTS.

    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. THIS COMPLAINT IS ASSOCIATED TO FIELD ACTION # 2243072-05/09/2019-007-R. RECALL SUMMARY: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR MULTIPLE LOTS OF THE BD MICROTAINER® TUBE W/ BD MICROGARDTM CLOSURE, K2EDTA ADDITIVE, BASED ON CONFIRMED COMPLAINTS OF REDUCED WITHIN THE TUBE RESERVOIR. PRODUCT AND SCOPE: BD MICROTAINER® TUBE W/ BD MICROGARDTM CLOSURE, K2EDTA ADDITIVE, CATALOG# 365974, ARE USED TO COLLECT, TRANSPORT AND STORE SKIN PUNCTURE BLOOD SPECIMENS FOR HEMATOLOGY TESTS, OR FOR TESTS UTILIZING SERUM OR HEPARINIZED PLASMA. DESCRIPTION OF ISSUE: THE REFERENCED LOTS HAVE BEEN CONFIRMED TO HAVE REDUCED OR NO ADDITIVE WITHIN THE TUBE RESERVOIR. BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE: PER 806 # 2243072-05/09/2019-007-R DATED JUNE 5, 2019 THERE WERE A TOTAL OF 2 COMPLAINTS AND 2 MDRS WITHIN SCOPE AT THE TIME THE FIELD ACTION WAS MADE. HHE SUMMARY: THIS ISSUE MAY DEVELOP VISIBLE CLOTS WITHIN THE TUBE SAMPLES OR MICRO CLOTS THAT ARE NOT EASILY DETECTED DURING VISUAL INSPECTION OF THE TUBES. AS A RESULT, THIS MAY LEAD TO RECOLLECTION OF SAMPLES OR, RETESTING OF PATIENTS, RESULTING IN DELAYED REPORTING OF TEST RESULTS AND PATIENT TREATMENT. . ADDITIONALLY, IF A MICRO CLOT IS UNDETECTED, IT MAY CONTRIBUTE TO INACCURATE CELL COUNTS INCLUDING PLATELET, AND HEMOGLOBIN LEVELS THAT COULD POTENTIALLY PRODUCE ERRONEOUS RESULTS THAT IMPACT PATIENT TREATMENT. THIS MAY LEAD TO MODERATE HEALTH HAZARD TO PATIENTS. BD PAS HAS INITIATED CAPA (B)(4) TO FURTHER INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z#. BD RECALL # PAS-19-1526.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLOTTING OCCURRED WITH BD MICROTAINER® TUBES WITH K2E (K2EDTA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I AM WRITING TO INFORM YOU OF A PROBLEM THAT I EXPERIENCED WITH A LOT OF BD MICROTAINER K2EDTA. IN THREE DAYS I HAD MULTIPLE PATIENT'S SAMPLES CLOT COMPLETELY SOLID. WE HAVE ALWAYS USED YOUR MICROTAINERS AND HAVE NEVER HAD A ISSUE IN THE PAST. ALL OF THE SAMPLES WERE EASILY OBTAINED AND WERE WELL MIXED. AFTER THE FIRST SAMPLE, I WAS VERY CONSCIOUS OF HOW WELL I WAS MIXING THE SAMPLES TO AVOID ANOTHER REDRAW. ALL OF THE TUBES WERE FROM THE SAME LOT OF K2EDTA MICROTAINERS : 9017593, EXP: 6/30/2020. WE HAVE REMOVED ALL OF THIS LOT OF TUBES." 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679227 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 9017593 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other