BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 8778554 · Received July 10, 2019

    Report

    Report Number
    2618282-2019-00221
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 30, 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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, THE ISSUE RELATING TO CLOTTING WAS OBSERVED. 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-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS CONDUCTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND THE INDICATED FAILURE MODE FOR CLOTTING WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: A CAPA WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. CAPA 896640. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THERE WAS AN ISSUE WITH CLOTTING. THIS OCCURRED ON 20 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMED THAT THEY HAVE BEEN HAVING CLOTTING ISSUES IN MICROTAINER EDTA TUBE. CUSTOMER NOTED THAT THIS ISSUE HAS BEEN HAPPENING FOR THE PAST 5-6 MONTHS. NO INFORMATION WAS PROVIDED ON FREQUENCY/ NO. OF SAMPLES IMPACTED AND WHETHER IF THERE WERE MULTIPLE LOT NUMBERS. CUSTOMER ONLY FURNISHED INFORMATION THAT THE MOST RECENT CASE IS FROM LOT NO. 9017600 (CAT NO. 365974) .

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9017600; MEDICAL DEVICE EXPIRATION DATE: 2020-06-30; DEVICE MANUFACTURE DATE: 2019-01-17. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. ADDITIONAL INFORMATION: INVESTIGATION IS ONGOING: REMEDIAL ACTION REQUIRED: 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. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# BD RECALL # PAS-19-1526.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) THERE WAS AN ISSUE WITH CLOTTING. THIS OCCURRED ON 20 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMED THAT THEY HAVE BEEN HAVING CLOTTING ISSUES IN MICROTAINER EDTA TUBE. CUSTOMER NOTED THAT THIS ISSUE HAS BEEN HAPPENING FOR THE PAST 5-6 MONTHS. NO INFORMATION WAS PROVIDED ON FREQUENCY/ NO. OF SAMPLES IMPACTED AND WHETHER IF THERE WERE MULTIPLE LOT NUMBERS. CUSTOMER ONLY FURNISHED INFORMATION THAT THE MOST RECENT CASE IS FROM LOT NO. 9017600 (CAT NO. 365974) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572725 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. SEE H.10 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Other