BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 8439688 · Received March 21, 2019

    Report

    Report Number
    1917413-2019-01035
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    November 16, 2018
    Report Date
    April 9, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 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 MISSING LABEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR MISSING LABEL WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. 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 · 0

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES WAS MISSING A LABEL ID. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "THE COMPLAINT PRODUCT WAS FOUND DURING LABELLING PROCESS AT (B)(6). WHEN WE REMOVE THE PRODUCT FROM THE CARTON WE FOUND THE PRODUCT WITH NO LABEL ID (INNER PACK) AS MANY AS 1 BOX (100 EA)".

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES WAS MISSING A LABEL ID. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "THE COMPLAINT PRODUCT WAS FOUND DURING LABELLING PROCESS AT AAM NDC CIKARANG. WHEN WE REMOVE THE PRODUCT FROM THE CARTON WE FOUND THE PRODUCT WITH NO LABEL ID (INNER PACK) AS MANY AS 1 BOX (100 EA)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234707 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8187607 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other