BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X100 5.0 PLBL GOLD

    MDR report key: 15352769 · Received September 2, 2022

    Report

    Report Number
    3003916417-2022-00182
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 5, 2022
    Report Date
    November 11, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2120763, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2022-06-09. MEDICAL DEVICE LOT #: 2090422, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2022-04-27.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO POOR CLOT FORMATION, FIBRIN, AND GEL SMEARING WERE OBSERVED. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE, POOR CLOT FORMATION, GEL SMEARING AND FIBRIN STRAND(S), BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE POOR CLOT FORMATION, FIBRIN, AND GEL SMEARING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO POOR CLOT FORMATION, FIBRIN, AND GEL SMEARING WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING TUBE SST PLH 13X100 5.0 PLBL GOLD COAGULATION DOES NOT OCCUR. AND THERE IS DETACHMENT OF THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS SAMPLE QUALITY CHANGES (CLOTTING CHANGES) WHEN USING THE 5ML GEL TUBE (360060) IN THE CENTRIFUGES OF THE UNIT. WITH 10 MINUTES OF CENTRIFUGATION AT 2800RPM, COAGULATION DOES NOT OCCUR, AND IN THE ROTATION OF 3000 RPM THERE IS DETACHMENT OF THE GEL. LOTS THAT SHOWED CHANGES: 2120763 AND 2090422.

    Description of Event or Problem · 0

    CUSTOMER REPORTS SAMPLE QUALITY CHANGES (CLOTTING CHANGES) WHEN USING THE 5ML GEL TUBE (360060) IN THE CENTRIFUGES OF THE UNIT. WITH 10 MINUTES OF CENTRIFUGATION AT 2800RPM, COAGULATION DOES NOT OCCUR, AND IN THE ROTATION OF 3000 RPM THERE IS DETACHMENT OF THE GEL. LOTS THAT SHOWED CHANGES: 2120763 AND 2090422. INFORMATION RECEIVED - 12.SEPT.2022. COAGULATION FAILURE: IN BOTH BATCHES (2090422 AND 2120763) WAS THERE CLOTTING FAILURE? NO. WAS THE TUBE FILLED WITH THE PROPER EXTRACTION VOLUME? YES. HOW MANY INVERSIONS WERE PERFORMED? AT LEAST 05 INVERSIONS. HOW LONG WAS THE BLOOD CLOTTED AFTER COLLECTION? 30 MINUTES. WHAT WAS THE TEMPERATURE (ROOM TEMPERATURE ETC.)? ROOM TEMPERATURE. IN WHAT POSITION WAS THE TUBE ALLOWED TO CLOT (VERTICALLY OR HORIZONTALLY)? VERTICALLY. WAS THE TUBE PLACED IN A PNEUMATIC TUBE SYSTEM PRIOR TO FULL CLOTTING? NO. HAS BLOOD SPILLED FROM AN ANTICOAGULATED TUBE INTO THE SALINE TUBE? NO. WAS BLOOD COLLECTED FROM A CATHETER THAT WAS NOT FLUSHED PRIOR TO BLOOD COLLECTION? NO. WAS THE APPROPRIATE AMOUNT OF BLOOD COLLECTED AND DISCARDED PRIOR TO COLLECTING THE BLOOD TUBE? YES. IS THE PATIENT ON ANTICOAGULANTS (EG, HEPARIN, COUMADIN®, ASPIRIN/IBUPROFEN)? SOMETIMES. DOES THE PATIENT HAVE A LIVER DISEASE OR BLEEDING DISORDER OR IS HE ON DIALYSIS? SOMETIMES. GEL RELEASE: COULD YOU DETAIL HOW THE GEL WOULD COME OFF? SMALL PARTICLES IN THE SERUM ARE OBSERVED WITH THE NAKED EYE AFTER CENTRIFUGATION. WAS FIBRIN PRESENT IN THE SERUM? PRESENCE OF FIBRIN WAS OBSERVED IN SOME SAMPLES. ARE TUBES BEING STORED AT ROOM TEMPERATURE AND AWAY FROM DIRECT SUNLIGHT THROUGHOUT THEIR DISTRIBUTION AND USE? YES. · HAVE THE RECOMMENDED SPIN G-FORCE, TIME AND TEMPERATURE BEEN OBSERVED? YES. ·WHEN WAS THE CENTRIFUGE CALIBRATION LAST CHECKED? AUGUST/2022. ·WHAT TYPE OF CENTRIFUGE WAS USED - FIXED ANGLE OR SWING BUCKET? OMEGA AND CENTURION. · WHAT IS THE SPIN ACCELERATION SPEED? 15 MINUTES AT 2800 RPM. ARE TUBES BEING TRANSPORTED FROM ONE LOCATION TO ANOTHER, IF SO, BY WHAT MEANS (PNEUMATIC TUBE, ROBOT, MANUAL TRANSPORT, MAIL, LAND VERSUS AIR)? TRANSPORT IS CARRIED OUT MANUALLY BY A LABORATORY TEAM. DOES THE PATIENT HAVE ABNORMALLY HIGH PROTEIN LEVELS (PROTEIN DISORDER)? CONSIDERING THAT WE HAD SEVERAL SAMPLES WITH THIS SAME PROBLEM, THE ISSUE OF INTERFERENCE RELATED TO THE CLINICAL CONDITION OF THE PATIENT WAS NOT CONSIDERED. COULD YOU FORWARD PHOTOS AND/OR VIDEOS THAT SHOW THE DEVIATION IN THE PRODUCT? YES (BUT CUSTOMER DID NOT SEND IT YET). IS THE INCIDENT-RELATED SAMPLE AVAILABLE FOR ANALYSIS? IF SO HOW MANY UNITS? (WE COLLECT A MAXIMUM OF 10 UNITS FOR ANALYSIS PURPOSES) YES, 3 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2446930 TUBE SST PLH 13X100 5.0 PLBL GOLD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown