BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 8713477 · Received June 19, 2019

    Report

    Report Number
    2618282-2019-00205
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 1, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE REGARDING DELAYED CLOTTING WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, LOW AMOUNTS OF ADDITIVE 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-CONFORMANCES 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 SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR DELAYED CLOTTING WITH THE INCIDENT LOT WAS NOT OBSERVED. EVALUATION/TESTING OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND LOW AMOUNTS OF ADDITIVE 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. ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQUIRED: RECALL THIS COMPLAINT IS ASSOCIATED TO FIELD ACTION # 2243072-05/09/2019-007-R. 1. 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. 2. 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. 3. 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 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE PER 806 # 2243072-05/09/2019-007-R DATED (B)(6)2019 THERE WERE A TOTAL OF(B)(4) COMPLAINTS AND(B)(4) MDRS WITHIN SCOPE AT THE TIME THE FIELD ACTION WAS MADE. 5. 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. 6. INVESTIGATION SUMMARY EVALUATION OF COMPLAINT SAMPLES CONFIRMED THAT ADDITIVE WAS NOT VISUALLY PRESENT INSIDE THE TUBES. SUBSEQUENTLY, RETENTION LOT SAMPLES FROM PRIOR AND POST MANUFACTURE OF THE COMPLAINT LOT WERE TESTED AND CONFIRMED THE DEFECT WAS LIMITED TO 13 LOTS MANUFACTURED FROM JANUARY 2019 TO FEBRUARY 2019. BD PAS HAS INITIATED CAPA 896640 TO FURTHER INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. 7.RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# BD RECALL # PAS-19-1526. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MICROTAINER® TUBES WITH K2E (K2EDTA) EXPERIENCED MISSING ADDITIVE NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 365974 BATCH NO. 9017593 IT WAS REPORTED THAT THERE WAS A DELAYED CLOTTING ISSUE. (3 OF 4) DATE OF EVENT (B)(6)2019. THEY ARE NOTICING A DELAYED CLOTTING ISSUES, IT WAS GREATER THAN 10 MINUTES. NO PATIENT IDENTIFIERS ADDTL INFO EMAIL: I RECENTLY REPORTED A PRODUCT ISSUE WITH THE EDTA MICROTAINER TUBES LOT#9017593, EXPIRATION 6/30/2020 ON BEHALF OF A USER FACILITY. A DELAYED CLOTTING ISSUE WAS IDENTIFIED WHEN WE HAD 5 INSTANCES ON DATES: (B)(6) 5/29X2 WHERE TESTING COULD NOT BE PERFORMED. WE HAVE SINCE REMOVED THIS LOT FROM USE AND HAVE UNUSED PRODUCT AVAILABLE TO SEND FOR FURTHER TESTING AND REPLACEMENT.

    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

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MICROTAINER® TUBES WITH K2E (K2EDTA) EXPERIENCED MISSING ADDITIVE NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 365974. BATCH NO. 9017593. IT WAS REPORTED THAT THERE WAS A DELAYED CLOTTING ISSUE. (3 OF 4) DATE OF EVENT (B)(6) 2019. THEY ARE NOTICING A DELAYED CLOTTING ISSUES, IT WAS GREATER THAN 10 MINUTES. NO PATIENT IDENTIFIERS. ADDTL INFO EMAIL: I RECENTLY REPORTED A PRODUCT ISSUE WITH THE EDTA MICROTAINER TUBES LOT # 9017593, EXPIRATION 6/30/2020 ON BEHALF OF A USER FACILITY. A DELAYED CLOTTING ISSUE WAS IDENTIFIED WHEN WE HAD 5 INSTANCES ON DATES: (B)(6) WHERE TESTING COULD NOT BE PERFORMED. WE HAVE SINCE REMOVED THIS LOT FROM USE AND HAVE UNUSED PRODUCT AVAILABLE TO SEND FOR FURTHER TESTING AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504280 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 9017593 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Other