BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAXGENE® BLOOD DNA TUBE

    MDR report key: 9385159 · Received November 27, 2019

    Report

    Report Number
    9617032-2019-01362
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 8, 2020
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE PAXGENE® BLOOD DNA TUBE THERE WAS AN ISSUE WITH OVER FILLING OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A RECENT ISSUE COMING FROM ONE OF OUR CLIENT SITES FROM AN ONGOING CLINICAL TRIAL STATING THEY HAD ISSUES WITH FILLING THE PAXGENE DNA BLOOD TUBE (SKU: 761165) LOT: 9008512. THEY SPECIFICALLY STATED THAT THE TUBE OVERFILLED (BEYOND THE MAX FILL LINE). THE TUBE COLLECTED APPROX. 4ML, 1.5ML OVER THE FILL VOLUME.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE PAXGENE® BLOOD DNA TUBE THERE WAS AN ISSUE WITH OVER FILLING OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD A RECENT ISSUE COMING FROM ONE OF OUR CLIENT SITES FROM AN ONGOING CLINICAL TRIAL STATING THEY HAD ISSUES WITH FILLING THE PAXGENE DNA BLOOD TUBE (SKU: 761165) LOT: 9008512. THEY SPECIFICALLY STATED THAT THE TUBE OVERFILLED (BEYOND THE MAX FILL LINE). THE TUBE COLLECTED APPROX. 4ML, 1.5ML OVER THE FILL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182223 PAXGENE® BLOOD DNA TUBE BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON AND COMPANY (BD) 9008512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other