BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 10153422 · Received June 15, 2020

    Report

    Report Number
    3003916417-2020-00166
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 26, 2020
    Report Date
    July 22, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD RECEIVED SAMPLES FROM THE CUSTOMER FOR EVALUATION. SEVEN PHOTOS WERE RECEIVED FOR EVALUATION. THE PHOTOS SHOW RED CELL HANG UP AND FIBRIN. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. ALL ANALYTES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. IN ADDITION, RESULTS FOR CELL SENSITIVE ANALYTES DEMONSTRATED CLINICAL EQUIVALENCE AND HEMOLYSIS INDEX SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE EVALUATION AND CONTROL TUBES. ALL LOTS ARE WITHIN THE SAME MANUFACTURING TIMEFRAME. SST¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY AT LEAST 5 COMPLETE AND GENTLE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE MINIMUM CLOTTING TIME FOR THE BD SST¿ TUBE (RECOMMENDED 30 MINUTE) IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING TIME) CAN RESULT IN THE FORMATION OF FIBRIN. THIS FIBRIN FORMATION MAY INTERFERE WITH BARRIER FORMATION. COMPLETE AND ADEQUATE BARRIER FORMATION IS DEPENDENT ON CENTRIFUGATION TIME, TEMPERATURE CONDITIONS AND G-FORCE. POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. TO ASSURE HIGH QUALITY SPECIMENS SEVERAL FACTORS ARE KEY. INCLUDED, BUT NOT LIMITED TO THIS ARE: PROPER PHLEBOTOMY TECHNIQUE TO MINIMIZE HEMOLYSIS AND PLATELET ACTIVATION, PROPER TUBE FILL VOLUME TO ASSURE THE PROPER BLOOD-TO-ADDITIVE RATION, GENTLE AND THOROUGH MIXING, PROPER CENTRIFUGATION CONDITIONS-G FORCE AND TIME, AND STORAGE CONDITIONS. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE, A DISCARD TUBE MUST BE USED TO FILL THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ WITH BLOOD. THE DISCARD DOES NOT NEED TO BE FILLED COMPLETELY. THE DISCARD TUBE SHOULD BE A NON-ADDITIVE OR COAGULATION TUBE. ADHERENCE TO THE RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. EVALUATION OF LABORATORY INSTRUMENTATION REGARDING REPRODUCIBILITY/REPEATABILITY MAY BE OF VALUE. IN ADDITION, DRUGS/MEDICATIONS CAN CHANGE THE DENSITY OF A BLOOD SPECIMEN, FURTHER CONTRIBUTING TO THIS REPORTED CONDITION. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. BASED ON THE DHR REVIEW AND THE INVESTIGATION PERFORMED, BD WAS UNABLE TO REPLICATE THE CUSTOMER ISSUE. HOWEVER, BASED ON THE REVIEW OF THE PHOTOS PROVIDED, THIS COMPLAINT HAS BEEN CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INCREASED SAMPLES WITH FIBRIN AFTER USE WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: INCIDENCE OF FIBRINS IN THE SAMPLES INCREASED. ADDITIONALLY, ON 2020-06-05 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: # OF TIMES SAMPLES ARE INVERTED AFTER COLLECTION: 3 ¿ 8 INVERTIONS. HOW WERE SAMPLES STORED TO CLOT? ¿ UPRIGHT, ON-SIDE¿ UPRIGHT . HOW LONG BLOOD WAS ALLOWED TO CLOT AFTER COLLECTION: MORE THAN 30 MINUTES. SPEED OF CENTRIFUGE AND TIME TO CENTRIFUGE: 2100G OR 3500 RPM (RATIO OF 15CM). SWING-HEAD OR FIXED ANGLE: SWING-HEAD. SPECIMEN STORAGE ¿ WERE THE SAMPLES REFRIGERATED AT ALL? THE SAMPLES ARE STORAGE AT ROOM TEMPERATURE (25O C). ANY INFORMATION ON THE PATIENTS THAT HAD THIS ISSUE: ARE THEY ON ANTICOAGULANT THERAPY? NO, THE SAMPLES AFFECTED COME FROM HEALTHY PATIENTS (DONORS), AND THEY ARE NOT IN ANTICOAGULANT THERAPY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE INCREASED SAMPLES WITH FIBRIN AFTER USE WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: INCIDENCE OF FIBRINS IN THE SAMPLES INCREASED. ADDITIONALLY, ON 2020-06-05 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: # OF TIMES SAMPLES ARE INVERTED AFTER COLLECTION: 3 ¿ 8 INVERSIONS. HOW WERE SAMPLES STORED TO CLOT? UPRIGHT, ON-SIDE. UPRIGHT. HOW LONG BLOOD WAS ALLOWED TO CLOT AFTER COLLECTION: MORE THAN 30 MINUTES. SPEED OF CENTRIFUGE AND TIME TO CENTRIFUGE: 2100G OR 3500 RPM (RATIO OF 15CM). SWING-HEAD OR FIXED ANGLE: SWING-HEAD. SPECIMEN STORAGE: WERE THE SAMPLES REFRIGERATED AT ALL? THE SAMPLES ARE STORAGE AT ROOM TEMPERATURE (25O C). ANY INFORMATION ON THE PATIENTS THAT HAD THIS ISSUE. ARE THEY ON ANTICOAGULANT THERAPY? NO, THE SAMPLES AFFECTED COME FROM HEALTHY PATIENTS (DONORS), AND THEY ARE NOT IN ANTICOAGULANT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620022 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 9304694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other