BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® TUBES WITH K2E (K2EDTA)

    MDR report key: 8596140 · Received May 9, 2019

    Report

    Report Number
    2618282-2019-00178
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 20, 2019
    Report Date
    June 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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: 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 JUNE 5, 2019 THERE WERE A TOTAL OF 2 COMPLAINTS AND 2 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED FOURTEEN (14) UNUSED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE FOURTEEN (14) SAMPLES ALONG WITH RETENTION SAMPLES (SELECTED FROM BD INVENTORY) WERE VISUALLY EVALUATED AND IT WAS CONFIRMED THAT THERE WAS NO ADDITIVE OBSERVED ON THE WALLS OF SEVERAL TUBES. THEN, TWO (2) RETENTION SAMPLES OBSERVED NOT HAVING ADDITIVE ON THE WALL OF THE TUBES WERE TESTED BY TITRATION AND A SMALL AMOUNT OF ADDITIVE WAS DETECTED. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER AND RETAIN SAMPLES, SEVERAL SAMPLES HAD NOT MET THE MINIMUM SPECIFICATION FOR ADDITIVE QUANTITY. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#896640. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA#896640 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: 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 AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MISSING ADDITIVE OCCURRED WITH A BD MICROTAINER® TUBES WITH K2E (K2EDTA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER NOTED THAT THEY HAVE BEEN EXPERIENCING FREQUENT CLOTTING IN MICROTAINER EDTA TUBES WITH THE NEW BATCH RECEIVED THE WEEK PRIOR. THE INCIDENT RATE IS HIGHER THAN USUAL (~20% INCIDENT RATE). CUSTOMER BLOOD COLLECTION PROCEDURE: FINGER PRICK USING ACCUCHECK LANCETS. BLOOD FILLING IS COMPLETED WITHIN 1-2 MINUTES. THE SPECIMEN COLLECTED IS FOR FBC COUNT. SUFFICIENT INVERSION IS DONE. CUSTOMER NOTED THAT THE COLLECTIONS ARE DONE BY EXPERIENCES PHLEBOTOMISTS, AND THAT THEY HAVE BEEN USING THE BD MICROTAINER K2EDTA TUBES FOR AT LEAST 5 YEARS WITHOUT ISSUE. CUSTOMER ALSO NOTED THAT THEY HAD ONE PATIENT WHO CAME IN FOR FBC. CAPILLARY BLOOD COLLECTED INTO THE MICROTAINER TUBE SHOWED LOW PLATELET. THE BLOOD COLLECTION WAS REPEATED USING VENOUS COLLECTION INTO VACUTAINER EDTA TUBE, WHICH THEN SHOWED THE RESULT YIELDING NORMAL PLATELET COUNT. CUSTOMER ALSO DID VISUAL INSPECTION OF THE TUBES AND FOUND THAT SOME TUBES DO NOT LOOK LIKE THEM CONTAIN ANY ADDITIVES. CUSTOMER THEN INVESTIGATED BY FILLING UP RANDOM MICROTAINER TUBES WITH BLOOD AND FOUND THAT SOME TUBES ALSO HAD CLOTTING ISSUE. FURTHER INVESTIGATION AND TUBE CLOTTING PATTERNS SHOWED THAT MICROTAINERS LABELLED WITH NO. 6 SEEM TO HAVE CLOTTING ISSUES. ON 23RD APRIL 2019, A BD ASSOCIATE WENT ON SITE, AND ALSO NOTED THAT SOME MICROTAINER EDTA TUBES DID NOT LOOK AS THOUGH THEY CONTAINED SPRAYED DRIED ADDITIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MISSING ADDITIVE OCCURRED WITH A BD MICROTAINER® TUBES WITH K2E (K2EDTA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER NOTED THAT THEY HAVE BEEN EXPERIENCING FREQUENT CLOTTING IN MICROTAINER EDTA TUBES WITH THE NEW BATCH RECEIVED THE WEEK PRIOR. THE INCIDENT RATE IS HIGHER THAN USUAL (~20% INCIDENT RATE) CUSTOMER BLOOD COLLECTION PROCEDURE: FINGER PRICK USING ACCUCHECK LANCETS. BLOOD FILLING IS COMPLETED WITHIN 1-2 MINUTES. THE SPECIMEN COLLECTED IS FOR FBC COUNT. SUFFICIENT INVERSION IS DONE CUSTOMER NOTED THAT THE COLLECTIONS ARE DONE BY EXPERIENCES PHLEBOTOMISTS, AND THAT THEY HAVE BEEN USING THE BD MICROTAINER K2EDTA TUBES FOR AT LEAST 5 YEARS WITHOUT ISSUE. CUSTOMER ALSO NOTED THAT THEY HAD ONE PATIENT WHO CAME IN FOR FBC. CAPILLARY BLOOD COLLECTED INTO THE MICROTAINER TUBE SHOWED LOW PLATELET. THE BLOOD COLLECTION WAS REPEATED USING VENOUS COLLECTION INTO VACUTAINER EDTA TUBE, WHICH THEN SHOWED THE RESULT YIELDING NORMAL PLATELET COUNT. CUSTOMER ALSO DID VISUAL INSPECTION OF THE TUBES AND FOUND THAT SOME TUBES DO NOT LOOK LIKE THEM CONTAIN ANY ADDITIVES. CUSTOMER THEN INVESTIGATED BY FILLING UP RANDOM MICROTAINER TUBES WITH BLOOD AND FOUND THAT SOME TUBES ALSO HAD CLOTTING ISSUE. FURTHER INVESTIGATION AND TUBE CLOTTING PATTERNS SHOWED THAT MICROTAINERS LABELLED WITH NO. 6 SEEM TO HAVE CLOTTING ISSUES. ON (B)(6) 2019, A BD ASSOCIATE WHEN ON SITE, AND ALSO NOTED THAT SOME MICROTAINER EDTA TUBES DID NOT LOOK AS THOUGH THEY CONTAINED SPRAYED DRIED ADDITIVE."

    Additional Manufacturer Narrative · 1

    (B)(6). 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

    HOLD FOR BRIAN 8-14-19IT WAS REPORTED THAT MISSING ADDITIVE OCCURRED WITH A BD MICROTAINER® TUBES WITH K2E (K2EDTA). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER NOTED THAT THEY HAVE BEEN EXPERIENCING FREQUENT CLOTTING IN MICROTAINER EDTA TUBES WITH THE NEW BATCH RECEIVED THE WEEK PRIOR. THE INCIDENT RATE IS HIGHER THAN USUAL (~20% INCIDENT RATE). CUSTOMER BLOOD COLLECTION PROCEDURE: FINGER PRICK USING ACCUCHECK LANCETS. BLOOD FILLING IS COMPLETED WITHIN 1-2 MINUTES. THE SPECIMEN COLLECTED IS FOR FBC COUNT. SUFFICIENT INVERSION IS DONE. CUSTOMER NOTED THAT THE COLLECTIONS ARE DONE BY EXPERIENCES PHLEBOTOMISTS, AND THAT THEY HAVE BEEN USING THE BD MICROTAINER K2EDTA TUBES FOR AT LEAST 5 YEARS WITHOUT ISSUE. CUSTOMER ALSO NOTED THAT THEY HAD ONE PATIENT WHO CAME IN FOR FBC. CAPILLARY BLOOD COLLECTED INTO THE MICROTAINER TUBE SHOWED LOW PLATELET. THE BLOOD COLLECTION WAS REPEATED USING VENOUS COLLECTION INTO VACUTAINER EDTA TUBE, WHICH THEN SHOWED THE RESULT YIELDING NORMAL PLATELET COUNT. CUSTOMER ALSO DID VISUAL INSPECTION OF THE TUBES AND FOUND THAT SOME TUBES DO NOT LOOK LIKE THEM CONTAIN ANY ADDITIVES. CUSTOMER THEN INVESTIGATED BY FILLING UP RANDOM MICROTAINER TUBES WITH BLOOD AND FOUND THAT SOME TUBES ALSO HAD CLOTTING ISSUE. FURTHER INVESTIGATION AND TUBE CLOTTING PATTERNS SHOWED THAT MICROTAINERS LABELLED WITH NO. 6 SEEM TO HAVE CLOTTING ISSUES. ON 23RD APRIL 2019, A BD ASSOCIATE WHEN ON SITE, AND ALSO NOTED THAT SOME MICROTAINER EDTA TUBES DID NOT LOOK AS THOUGH THEY CONTAINED SPRAYED DRIED ADDITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387084 BD MICROTAINER® TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 9017600 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1 Other