BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 8241924 · Received January 11, 2019

    Report

    Report Number
    9617032-2018-03354
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    August 30, 2017
    Report Date
    February 21, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679572
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT THE EVACUATED BLOOD COLLECTION TUBE IVD EXPERIENCED TWENTY THREE CASES OF UNDER FILLING DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7030692. MEDICAL DEVICE EXPIRATION DATE: 2018-07-31. DEVICE MANUFACTURE DATE: 2017-01-30. MEDICAL DEVICE LOT #: 6237608. MEDICAL DEVICE EXPIRATION DATE: 2018-02-28. DEVICE MANUFACTURE DATE: 2016-08-24. MEDICAL DEVICE LOT #: 7018596. MEDICAL DEVICE EXPIRATION DATE: 2018-07-31. DEVICE MANUFACTURE DATE: 2017-01-18. MEDICAL DEVICE LOT #: 7066860. MEDICAL DEVICE EXPIRATION DATE: 2018-08-31. DEVICE MANUFACTURE DATE: 2017-03-07. 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 THE EVACUATED BLOOD COLLECTION TUBE IVD EXPERIENCED TWENTY THREE CASES OF UNDER FILLING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33642 BD VACUTAINER® SST¿ II ADVANCE EVACUATED BLOOD COLLECTION TUBE IVD JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903679572

    Patients

    Seq Age Sex Outcome Treatment
    1 Other