BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD BLOOD COLLECTION TUBE

    MDR report key: 8714193 · Received June 19, 2019

    Report

    Report Number
    1917413-2019-01610
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    June 5, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL 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 RETAIN 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.

    Additional Manufacturer Narrative · 0

    PMA/510(K)# K013971.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDERFILL OCCURRED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHILE ON THE PHONE THE CLIENT MENTIONED THE UNDER FILING PROBLEM OF THE SODIUM CITRATE TUBES AND WOULD LIKE A CALL BACK. HE HAS REPORTED THIS TO BD PREVIOUSLY BUT IT WAS A LONG TIME AGO AND THE PROBLEM STILL EXISTS.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDERFILL OCCURRED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHILE ON THE PHONE THE CLIENT MENTIONED THE UNDER FILING PROBLEM OF THE SODIUM CITRATE TUBES AND WOULD LIKE A CALL BACK. HE HAS REPORTED THIS TO BD PREVIOUSLY BUT IT WAS A LONG TIME AGO AND THE PROBLEM STILL EXISTS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERFILL OCCURRED WITH A BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHILE ON THE PHONE THE CLIENT MENTIONED THE UNDER FILING PROBLEM OF THE SODIUM CITRATE TUBES AND WOULD LIKE A CALL BACK. HE HAS REPORTED THIS TO BD PREVIOUSLY BUT IT WAS A LONG TIME AGO AND THE PROBLEM STILL EXISTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504636 UNSPECIFIED BD BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9036653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other