BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 16714758 · Received April 11, 2023

    Report

    Report Number
    1917413-2023-00283
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 15, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903688611
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE LOT #: 2153626 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. IT IS HOWEVER FOR A 368861 (BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES). BD WAS UNABLE TO CONFIRM WITH CUSTOMER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AFTER TESTING WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE OBTAINED, MAINLY HEMOGLOBIN. SPECIFIC PATIENT INFORMATION WAS NOT ABLE TO BE OBTAINED. REPEAT TESTING WAS PERFORMED. ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CBC VALUES SHOW SIGNIFICANT VARIATION IN PATIENTS AT HOSPITAL, MAINLY PARAMETERS SUCH AS HEMOGLOBIN IS SIGNIFICANTLY CHANGES, DUE TO THIS THERE HAVE BEEN SEVERAL REPEAT TESTS THE HOSPITAL HAD TO RUN FOR SAME PATIENTS. D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON AND COMPANY (BD) ¿ PLYMOUTH, UNITED KINGDOM / PL6 7BP. D.4 MEDICAL DEVICE CATALOG #: 368861. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2023. D.4. UNIQUE IDENTIFIER (UDI) #:(B)(4). G.1 MANUFACTURING LOCATION: BECTON, DICKINSON AND COMPANY (BD) ¿ PLYMOUTH, UNITED KINGDOM / PL6 7BP. H.4. DEVICE MANUFACTURE DATE: 02-JUN-2022.

    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 ERRONEOUS RESULTS WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS-HEMOGLOBIN) 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. LABORATORY ANALYSIS OF RETAIN AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. 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 UNCONFIRMED FOR ERRONEOUS RESULTS-HEMOGLOBIN. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS 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 THAT AFTER TESTING WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE OBTAINED, MAINLY HEMOGLOBIN. SPECIFIC PATIENT INFORMATION WAS NOT ABLE TO BE OBTAINED. REPEAT TESTING WAS PERFORMED. ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CBC VALUES SHOW SIGNIFICANT VARIATION IN PATIENTS AT HOSPITAL, MAINLY PARAMETERS SUCH AS HEMOGLOBIN IS SIGNIFICANTLY CHANGES, DUE TO THIS THERE HAVE BEEN SEVERAL REPEAT TESTS THE HOSPITAL HAD TO RUN FOR SAME PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER TESTING WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE OBTAINED, MAINLY HEMOGLOBIN. SPECIFIC PATIENT INFORMATION WAS NOT ABLE TO BE OBTAINED. REPEAT TESTING WAS PERFORMED. ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CBC VALUES SHOW SIGNIFICANT VARIATION IN PATIENTS AT HOSPITAL, MAINLY PARAMETERS SUCH AS HEMOGLOBIN IS SIGNIFICANTLY CHANGES, DUE TO THIS THERE HAVE BEEN SEVERAL REPEAT TESTS THE HOSPITAL HAD TO RUN FOR SAME PATIENTS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER TESTING WITH AN UNSPECIFIED AMOUNT OF BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ERRONEOUS RESULTS WERE OBTAINED, MAINLY HEMOGLOBIN. SPECIFIC PATIENT INFORMATION WAS NOT ABLE TO BE OBTAINED. REPEAT TESTING WAS PERFORMED. ERRONEOUS RESULTS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CBC VALUES SHOW SIGNIFICANT VARIATION IN PATIENTS AT HOSPITAL, MAINLY PARAMETERS SUCH AS HEMOGLOBIN IS SIGNIFICANTLY CHANGES, DUE TO THIS THERE HAVE BEEN SEVERAL REPEAT TESTS THE HOSPITAL HAD TO RUN FOR SAME PATIENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402328 BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367861 2153626 50382903688611

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown