BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 12235803 · Received July 27, 2021

    Report

    Report Number
    3003916417-2021-00185
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 22, 2021
    Report Date
    October 26, 2021
    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

    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 ERRONEOUS RESULTS/STOPPER ISSUE WERE OBSERVED. (B)(4) SAMPLES FROM EACH BATCH WERE VISUALLY EVALUATED. FOR STOPPER FUNCTION THE PRODUCT WAS EVALUATED TO SEE IF THERE WERE NO STOPPER LOOSE AND THE PRODUCT WAS PROPERLY CAPPED. FOR ERRONEOUS RESULTS THE PRODUCT WAS EVALUATED TO VERIFY IF THERE WOULD BE ANY ADDITIVE ABNORMALITY (SPRAY PATTERN OR ADDITIVE COLOR VARIATION) AND THE PRODUCT WAS ACCORDING SPECIFICATION. FOR DIFFICULT TO INSERT STOPPERS NO TEST WAS EXECUTED SINCE THERE IS NO REQUIREMENT OR ACCEPTANCE CRITERIA TO BE EVALUATED BASED ON BD SPECIFICATIONS. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS/STOPPER ISSUE) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. THERE WERE NO STOPPER ISSUES NOTED. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. THE EDTA TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THE BATCH HISTORY REVIEW FOR BATCH 1051669 WAS SATISFACTORY PER INTERNAL PROCEDURES. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS/STOPPER ISSUE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS/STOPPER ISSUE 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR, THE DEVICE EXPERIENCED ERRONEOUS RESULTS, AND DIFFICULTY /UNABLE TO PIERCE THROUGH THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN THE FORM ATTACHED, IT STATES THAT IN THE BATCH # 1051669 THE SAMPLE PRESENTS INDICATORS OF ALTERATION OF PLATELETS IN THE ANALYZER USED, SUCH AS SUSPECT PLATELETS AND ABNORMALITY OF PLATELETS. STOPPER IS HARD TO BE RECAPPED AFTER OPENED.

    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 WHEN USING THE TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR, THE DEVICE EXPERIENCED ERRONEOUS RESULTS, AND DIFFICULTY /UNABLE TO PIERCE THROUGH THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN THE FORM ATTACHED, IT STATES THAT IN THE BATCH # 1051669 THE SAMPLE PRESENTS INDICATORS OF ALTERATION OF PLATELETS IN THE ANALYZER USED, SUCH AS SUSPECT PLATELETS AND ABNORMALITY OF PLATELETS. STOPPER IS HARD TO BE RECAPPED AFTER OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131688 TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 1051669

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown