BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 7559555 · Received June 1, 2018

    Report

    Report Number
    9617032-2018-01287
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    January 1, 2016
    Report Date
    May 8, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5233476 MEDICAL DEVICE EXPIRATION DATE: 01/31/2017 DEVICE MANUFACTURE DATE: 08/21/2015; MEDICAL DEVICE LOT #: 6235740 MEDICAL DEVICE EXPIRATION DATE: 01/31/2018 DEVICE MANUFACTURE DATE: 08/22/2016; MEDICAL DEVICE LOT #: 6251813 MEDICAL DEVICE EXPIRATION DATE: 03/31/2018 DEVICE MANUFACTURE DATE: 09/07/2016; MEDICAL DEVICE LOT #: 7004755 MEDICAL DEVICE EXPIRATION DATE: 06/30/2018 DEVICE MANUFACTURE DATE: 01/04/2017; MEDICAL DEVICE LOT #: 7093775 MEDICAL DEVICE EXPIRATION DATE: 08/31/2018 DEVICE MANUFACTURE DATE: 04/03/2017; MEDICAL DEVICE LOT #: 7173558 MEDICAL DEVICE EXPIRATION DATE: 12/31/2018 DEVICE MANUFACTURE DATE: 06/22/2017; MEDICAL DEVICE LOT #: 7325894 MEDICAL DEVICE EXPIRATION DATE: 04/30/2019 DEVICE MANUFACTURE DATE: 11/21/2017. PMA / 510(K) #: UNKNOWN. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED AND EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOGGED INSTRUMENTATION WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOGGED INSTRUMENTATION WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES HAD ISSUES WITH THE INSTRUMENTATION CLOGGING FREQUENTLY. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402243 BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5201056

    Patients

    Seq Age Sex Outcome Treatment
    1 Other