BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® PST¿ UNITS BLOOD COLLECTION TUBES

    MDR report key: 8359462 · Received February 21, 2019

    Report

    Report Number
    1917413-2019-00298
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    January 31, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903679621
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE CUSTOMER SAMPLES WERE EVALUATED ALONG WITH RETENTION SAMPLES OF THE INCIDENT LOT SELECTED FROM BD INVENTORY. THE CUSTOMER AND RETENTION SAMPLES WERE TESTED AND NO ISSUES RELATING TO ELEVATED AST WERE OBSERVED AS ALL RESULTS DEMONSTRATED SATISFACTORY PERFORMANCE. 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 AND RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ELEVATED AST 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES WERE RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. NO PHOTOS OF THE INCIDENT WERE RECEIVED FROM THE CUSTOMER FACILITY. (B)(4) PRODUCTION LOT IN-HOUSE RETENTION SAMPLES WERE SENT TO (B)(4) FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE NOT ABLE TO BE REVIEWED SAFELY DUE TO WATER/MOLD DAMAGE. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. INVESTIGATION CONCLUSION: NO SAMPLES WERE SENT TO THE MANUFACTURING SITE FOR EVALUATION. NO PHOTOS OF THE INCIDENT WERE RECEIVED FROM THE CUSTOMER FACILITY. (B)(4) PRODUCTION LOT IN-HOUSE RETENTION SAMPLES WERE SENT TO (B)(4) FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE NOT ABLE TO BE REVIEWED SAFELY DUE TO WATER/MOLD DAMAGE. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. FURTHER CLINICAL INVESTIGATION OF CUSTOMER SAMPLES WILL BE COMPLETED BY (B)(4). ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AFTER REVIEW OF THE MANUFACTURING RECORDS. FRANKLIN LAKES WILL UPDATE INVESTIGATION. RATIONALE: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS RECEIVED NO CUSTOMER SAMPLES TO (B)(4), NO CUSTOMER SAMPLES WERE RECEIVED AT THE MANUFACTURING SITE. (B)(4) PRODUCTION LOT IN-HOUSE RETENTION SAMPLES WERE SENT TO (B)(4) FOR FURTHER CLINICAL TESTING. THE DEVICE HISTORY RECORDS WERE NOT ABLE TO BE REVIEWED SAFELY DUE TO WATER/MOLD DAMAGE. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 83 UNITS BLOOD COLLECTION TUBE EXPERIENCED ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150213 BD VACUTAINER® PST¿ UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 8099814 00382903679621

    Patients

    Seq Age Sex Outcome Treatment
    1 Other