BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 14026993 · Received April 6, 2022

    Report

    Report Number
    9617032-2022-00307
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 23, 2022
    Report Date
    September 14, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    KDT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS FOR THE FOLLOWING COMPLAINTS FOR ELEVATED RBC COUNTS: MATERIAL # 364941, LOT#: 1230641. BD RECEIVED RETURN SAMPLES ON LOT # 1186876 FOR INVESTIGATION. DEVICE HISTORY RECORD (DHR REVIEW) OF LOT #'S 0272232, 1186876, 0247853, 1230641: 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. COMPLAINT HISTORY REVIEW: NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THESE LOT NUMBERS AND NO SIMILAR COMPLAINTS WERE FOUND ON THESE MATERIAL NUMBERS (36915 AND 364941) WITHIN THE PAST 18 MONTHS. IN 2020 A NUMBER OF COMPLAINTS REGARDING ERRONEOUS RBC DETERMINATIONS WHEN BD URINE CUPS WERE USED IN CONJUNCTION WITH SYSMEX INSTRUMENTS WERE REPORTED. FURTHER INVESTIGATION IDENTIFIED A LINK BETWEEN THE AMOUNT OF LUBE APPLIED TO THE SAMPLE NEEDLE IN THE URINE CUP AND THESE ELEVATED RBC RESULTS WHEN USING THE SYSMEX INSTRUMENT. A PRODUCT NOTIFICATION WAS PROVIDED TO SYSMEX ALERTING THEM TO THIS FACT AND INFORMING THEM THAT ¿IMPROVED¿ URINE CUPS (I.E. WITH LESS LUBE) WOULD BEGIN PRODUCTION BY OCTOBER 2020. THE LOWER LUBE LEVEL NEEDLES WERE NOT IN PRODUCTION UNTIL LOT 1060502 MANUFACTURED IN MARCH 2021. - LOT # 0247853 WAS MANUFACTURED PRIOR TO THE CHANGE. LOT # 1230641 WAS MANUFACTURED AFTER THE CHANGE. CLINICAL TESTING WAS PERFORMED ON RETAINS FOR MATERIAL # 364941 (URINE CUP), RETAINS FOR MATERIAL # 364915 (TUBE URINE PLH 16X100 UA BEIGE) LOT 1186876, 0272232, CUSTOMER PROVIDED MATERIAL # 364915, LOT 1186876, AND CONTROL SAMPLES. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING URINE COLLECTION AND SUBSEQUENT TUBE FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE (ELEVATED RBC'S) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF CUSTOMER, RETAIN AND CONTROL SAMPLES WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. ALL TUBES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR ERRONEOUS RESULTS(ELEVATED RBC'S). THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR ERRONEOUS RESULTS. TO DATE BD HAS BEEN UNABLE TO REPLICATE THE REPORTED ISSUE OF FALSELY ELEVATED RBCS DURING AUTOMATED URINALYSIS WHILE USING THE URINE CUP WITH THE INTEGRATED TRANSFER DEVICE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ELEVATED RBC'S 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP THERE WERE ERRONEOUS RESULTS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN USING THE BD VACUTAINER URINE COLLECTION SYSTEM AN ELEVATED RBCS COUNT IN URINALYSIS WAS NOTICE. A COMPARISON STUDY WAS PERFORMED IN WHICH URINE SAMPLES WERE COLLECTED IN BOTH THE OLD CONTAINER AND BD COLLECTION SYSTEM .¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP THERE WERE ERRONEOUS RESULTS. THIS EVENT OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN USING THE BD VACUTAINER URINE COLLECTION SYSTEM AN ELEVATED RBCS COUNT IN URINALYSIS WAS NOTICE. A COMPARISON STUDY WAS PERFORMED IN WHICH URINE SAMPLES WERE COLLECTED IN BOTH THE OLD CONTAINER AND BD COLLECTION SYSTEM .¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901193 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER KDT BECTON, DICKINSON AND COMPANY (BD) 1230641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown