BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8549663 · Received April 25, 2019

    Report

    Report Number
    1024879-2019-00765
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 10, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR MIXED PRODUCT WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND MIXED PRODUCT 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. BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR MIXED PRODUCTS WITH THE INCIDENT LOT WAS OBSERVED. 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 THE CASE OF CATALOG # 367986, LOT # 9011610 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ONE PACK OF TUBES WITHIN LABELED CATALOG # 368159, LOT # 9010908. THE MIXED PRODUCT ERROR WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITHIN A CASE OF BD # 367986 - 5ML SST VACUTAINER LOT# 9011610 TUBES, THE PRODUCTION TEAM FOUND ONE 1 PACK OF TUBES LABELED BD # 368159 5ML ¿ SST VACUTAINER LOT# 9010908. THE WAREHOUSE CONFIRMED THAT IT APPEARS THE BALANCE OF THE LOT# SEEMS TO HAVE THE CORRECTLY LABELED TUBES WITHIN THE CASE, ALTHOUGH WE DO NOT KNOW IF THERE ARE POTENTIAL MIXED TUBES WITHIN EACH PACK, AS WE DID NOT OPEN PACKS TO VERIFY EACH TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 CASE OF CATALOG #: 367986, LOT #: 9011610 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ONE PACK OF TUBES WITHIN LABELED CATALOG #: 368159, LOT #: 9010908. THE MIXED PRODUCT ERROR WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITHIN A CASE OF BD #: 367986 - 5ML SST VACUTAINER LOT#: 9011610 TUBES, THE PRODUCTION TEAM FOUND ONE 1 PACK OF TUBES LABELED BD #: 368159 5ML ¿ SST VACUTAINER LOT#: 9010908. THE WAREHOUSE CONFIRMED THAT IT APPEARS THE BALANCE OF THE LOT# SEEMS TO HAVE THE CORRECTLY LABELED TUBES WITHIN THE CASE, ALTHOUGH WE DO NOT KNOW IF THERE ARE POTENTIAL MIXED TUBES WITHIN EACH PACK, AS WE DID NOT OPEN PACKS TO VERIFY EACH TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343610 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9011610 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other