BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 15421875 · Received September 14, 2022

    Report

    Report Number
    9617032-2022-00879
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 25, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    PJE
    UDI-DI
    54053727611654
    PMA / PMN Number
    K142821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 #: 1210563. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2022. DEVICE MANUFACTURE DATE: 29-JUL-2021. MEDICAL DEVICE LOT #: 1246399. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2022. DEVICE MANUFACTURE DATE: 03-SEP-2021. MEDICAL DEVICE LOT #: 2041397. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2023. DEVICE MANUFACTURE DATE: 10-FEB-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 2022-09-22. H.6. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES FROM EACH LOT. UNFORTUNATELY, THERE IS NO TESTING THAT CAN BE DONE FOR LOW YIELD. OUR IFU (INSTRUCTIONS FOR USE) DOES NOT PROVIDE FOR ANY SPECIFIC YIELD CLAIMS. YIELDS DEPEND ON THE PATIENT, THE QUALITY OF THE SPECIMEN, AND THE METHOD USED FOR ISOLATION. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBERS: 1210563, 1246399, 2041397 THE ¿AS REPORTED¿ DEFECT CODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THIS COMPLAINT IS UNABLE TO BE CONFIRMED LOW YIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A REVIEW OF OUR IFU IS RECOMMENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS MISSING ADDITIVE. THIS EVENT AFFECTED 103,550 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PRODUCT IS PRESENTING LOW YIELD. MOST SAMPLES FAILING DNA EXTRACTION QC ARE FAILING CONCENTRATION."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PAXGENE® BLOOD DNA TUBE THERE WAS MISSING ADDITIVE. THIS EVENT AFFECTED (B)(4) DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PRODUCT IS PRESENTING LOW YIELD. MOST SAMPLES FAILING DNA EXTRACTION QC ARE FAILING CONCENTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675305 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 761165 SEE H.10 54053727611654

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown