BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 8663069 · Received June 3, 2019

    Report

    Report Number
    9617032-2019-00640
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    UDI-DI
    54053727611654
    PMA / PMN Number
    K142821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. 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. 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. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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 PAXGENE® BLOOD DNA TUBE WAS EXPERIENCING LOW DRAW. THIS OCCURRED ON 2 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 761165 BATCH NO: 8164968. IT WAS REPORTED THE TUBE IS NOT WORKING AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THE LOT NUMBER FOR BOTH THE OPENED, DYSFUNCTIONAL TUBES, AND THE UNOPENED TUBE PACKAGE THAT WE HAVE IS THE SAME. IT IS 8164968. THIS IMPLIES TO ME THAT THE UNOPENED PACKAGE WOULD NOT WORK EITHER. THE TUBE IS NOT WORKING FOR US AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THIS IS CAUSING LITTLE TO NO BLOOD FLOW INTO THE TUBE AND PREVENTING US FROM COLLECTING THIS SAMPLE TYPE.

    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 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 PAXGENE® BLOOD DNA TUBE WAS EXPERIENCING LOW DRAW. THIS OCCURRED ON 2 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 761165, BATCH NO: 8164968 IT WAS REPORTED THE TUBE IS NOT WORKING AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THE LOT NUMBER FOR BOTH THE OPENED, DYSFUNCTIONAL TUBES, AND THE UNOPENED TUBE PACKAGE THAT WE HAVE IS THE SAME. IT IS 8164968. THIS IMPLIES TO ME THAT THE UNOPENED PACKAGE WOULD NOT WORK EITHER. THE TUBE IS NOT WORKING FOR US AS THE VACUUM SEAL CREATED BETWEEN THE TUBE AND THE VACUTAINER APPEARS TO BE VERY WEAK. THIS IS CAUSING LITTLE TO NO BLOOD FLOW INTO THE TUBE AND PREVENTING US FROM COLLECTING THIS SAMPLE TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455037 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 8164968 54053727611654

    Patients

    Seq Age Sex Outcome Treatment
    1 Other