BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 8629111 · Received May 21, 2019

    Report

    Report Number
    9617032-2019-00609
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 17, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    PMA / PMN Number
    K142821
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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 CUSTOMER AND 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 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 200 PAXGENE® BLOOD DNA TUBES FROM LOT # 9008512 AND AN UNSPECIFIED NUMBER OF TUBES FROM LOT # 8108757 UNDERFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNDERFILL OF PAXGENE DNA TUBES. CUSTOMER USES PAXGENE DNA TUBES 761165. HAS TWO SEPARATE LOTS AND WITH BOTH OF THESE THEY EXPERIENCE SIGNIFICANT UNDERFILL OF THE TUBES. LOT NUMBERS: 1) 8108757 MHD 31.05.2019; 2) 9008512 MHD 31.01.2020. AT THE SAME TIME THEY ALSO USE PAXGENE RNA TUBES THAT SHOW NO PROBLEMS. BOTH TUBES ARE FILLED AT SAME TIME POINT WITH SAME NEEDLE AND HOLDER."

    Additional Manufacturer Narrative · 1

    (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9008512, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 8108757, MEDICAL DEVICE EXPIRATION DATE: 2019-05-31, DEVICE MANUFACTURE DATE: 2018-04-18. 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 200 PAXGENE® BLOOD DNA TUBES FROM LOT # 9008512, AND AN UNSPECIFIED NUMBER OF TUBES FROM LOT # 8108757 UNDERFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNDERFILL OF PAXGENE DNA TUBES. CUSTOMER USES PAXGENE DNA TUBES 761165. HAS TWO SEPARATE LOTS AND WITH BOTH OF THESE THEY EXPERIENCE SIGNIFICANT UNDERFILL OF THE TUBES. LOT NUMBERS: 8108757 EXP 31.05.2019, 9008512 EXP 31.01.2020. AT THE SAME TIME THEY ALSO USE PAXGENE RNA TUBES THAT SHOW NO PROBLEMS. BOTH TUBES ARE FILLED AT SAME TIME POINT WITH SAME NEEDLE AND HOLDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422641 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other