BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGENE HC2 DNA COLLECTION DEVICE

    MDR report key: 5976768 · Received September 26, 2016

    Report

    Report Number
    1122376-2016-00014
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 26, 2016
    Manufacturer
    QIAGEN
    Product Code
    HHT
    UDI-DI
    14053228010354
    PMA / PMN Number
    K971586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO IRREGULARITIES NOTED DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURN. REMAINING CUSTOMER INVENTORY WAS INSPECTED AND ONE ADDITIONAL DEVICE WAS FOUND TO BE DEFECTIVE. AN EVALUATION OF THIS DEVICE WAS PERFORMED AND CONCLUDED THAT THE CAUSE FOR THE BRUSH DETACHMENT WAS THAT IT MISSED THE HEATING PROCESS WHICH AIDS IN ADHERING THE BRUSH TO THE STEM. FURTHER INVESTIGATION IS PENDING. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    ON (B)(6) 2016 (B)(6) RECEIVED A REPORT, (B)(6) FROM (B)(6) INDUSTRIAL HEALTH ASSOCIATION IN (B)(6) OF AN INCIDENT WHERE THE BRUSH HEAD BECAME DETACHED FROM THE SHAFT AND REMAINED INSIDE THE PATIENT. THE BRUSH WAS IMMEDIATELY REMOVED FROM THE PATIENT WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627926 DIGENE HC2 DNA COLLECTION DEVICE DIGENE HC2 DNA COLLECTION DEVICE HHT QIAGEN M1995 14053228010354

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR