BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 10340658 · Received July 29, 2020

    Report

    Report Number
    3003916417-2020-00218
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 9, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS, RED CELL HANG UP AND POOR BARRIER SEPARATION DURING USE. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE GEL DID NOT SEPARATE, IT SEEMS THERE IS A LOT OF FIBRIN INSIDE THE TUBE." ADDITIONAL INFORMATION: 10 TUBES AFFECTED, ALL TUBE EXPERIENCED FIBRIN MASS. CLOT ACTIVATOR ON TUBE WALL. BLOOD CLOTTED AFTER COLLECTION. MAINTENANCE OF CENTRIFUGE UP TO DATE. H.6. FDA DEVICE PROBLEM CODE(S): 1096, 1535 H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR RED CELL HANG-UP, AND POOR BARRIER SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. IT WAS NOT POSSIBLE TO TO VERIFY THE PRESENCE OF FIBRIN FROM THE PHOTOS RECEIVED. EVALUATING THE EVENT DETAILS PROVIDED IN THE COMPLAINT, IT WAS OBSERVED THAT THE TUBES ARE KEPT IN A HORIZONTAL POSITION AND WITH A MAXIMUM CLOTTING TIME OF 25 MINUTES (15 MINUTES OF RETENTION TIME + 8 TO 10 MINUTES OF CLOTTING TIME), AND THE CORRECT METHOD IS TO KEEP THE PRODUCT IN AN VERTICAL POSITION WITH A MINIMUM CLOTTING TIME OF 30 MINUTES FOR PATIENTS WITHOUT CLOTTING PROBLEMS. 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 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF FIBRIN AND RED CELL HANG-UP THROUGH CORRECTIVE AND PREVENTIVE ACTIONS, CAPA#1654520. 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 THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS, RED CELL HANG UP AND POOR BARRIER SEPARATION DURING USE. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE GEL DID NOT SEPARATE, IT SEEMS THERE IS A LOT OF FIBRIN INSIDE THE TUBE." ADDITIONAL INFORMATION: 10 TUBES AFFECTED, ALL TUBE EXPERIENCED FIBRIN MASS. CLOT ACTIVATOR ON TUBE WALL. BLOOD CLOTTED AFTER COLLECTION. MAINTENANCE OF CENTRIFUGE UP TO DATE.

    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 THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS DURING USE. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE GEL DID NOT SEPARATE, IT SEEMS THERE IS A LOT OF FIBRIN INSIDE THE TUBE." ADDITIONAL INFORMATION: 10 TUBES AFFECTED, ALL TUBE EXPERIENCED FIBRIN MASS. CLOT ACTIVATOR ON TUBE WALL. BLOOD CLOTTED AFTER COLLECTION. MAINTENANCE OF CENTRIFUGE UP TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806067 TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 9241907

    Patients

    Seq Age Sex Outcome Treatment
    1 Other