BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD P800 BLOOD COLLECTION SYSTEM FOR PLASMA METABOLIC BIOMARKER PRESERVATION

    MDR report key: 7549061 · Received May 29, 2018

    Report

    Report Number
    1917413-2018-02052
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    December 20, 2017
    Report Date
    May 16, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR NON-COMPLIANT GHS LABEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR NON-COMPLIANT GHS LABEL WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. A CAPA WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD P800 BLOOD COLLECTION SYSTEM FOR PLASMA METABOLIC BIOMARKER PRESERVATION K2 EDTA HAD A NON-COMPLIANT SYMBOL ON THE LABEL. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393678 BD P800 BLOOD COLLECTION SYSTEM FOR PLASMA METABOLIC BIOMARKER PRESERVATION BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7122744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other