BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 17486909 · Received August 9, 2023

    Report

    Report Number
    9617032-2023-01066
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. EVALUATION OF THE PHOTO INDICATED A TUBE WITH LARGER THAN NORMAL DROPLETS OF ADDITIVE ON THE TUBE WALL. DUE TO THIS, THE ADDITIVE HAS YELLOWED SLIGHTLY ON IRRADIATION. THIS IS RECOGNIZED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICACY OF THE TUBE. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO ADDITIVE ABNORMALITY WAS FOUND. BD WAS ABLE TO DUPLICATE AND CONFIRM THE CUSTOMERS¿ FAILURE MODE FROM THE PHOTO RECEIVED. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 ABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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 THAT WHILE USING THE BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES THAT THERE WAS FOREIGN MATTER IN TUBE; BIOLOGICAL AND NONBIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE SITES HAVE REPORTED AN ISSUE WITH AN INDIVIDUAL BD PURPLE TOP TUBE. THE HCP TOOK A NEW PACK OUT TO USE AND FOUND ONE OF THE TUBES WAS CONTAMINATED. LOT NUMBER 3093802.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904400 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3093802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown