BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGENE HC2 DNA COLLECTION DEVICE

    MDR report key: 5525063 · Received March 24, 2016

    Report

    Report Number
    1122376-2016-00010
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    QIAGEN
    Product Code
    HHT
    PMA / PMN Number
    K971586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 INCIDENT OCCURRED AND WAS REPORTED TO QIAGEN TECHNICAL SERVICE. ON (B)(6) 2016 DEVICE WAS REMOVED FROM PATIENT WITHOUT INJURY. ON 07MAR2016 DEVICE WAS RECEIVED AT QIAGEN FOR EVALUATION. UNUSED DEVICES FROM THE SAME KIT BOX WERE ALSO SENT FOR EVALUATION. ON 15MAR2016 DEFECTIVE DEVICE WAS INSPECTED SIDE BY SIDE WITH AN UNUSED DEVICE. THE AFFECTED DEVICE SHOWED NO EVIDENCE OF GOING THROUGH THE HEAT STEP IN THE ASSEMBLY PROCESS. THIS HEAT STEP HELPS SECURE THE BRUSH HEAD TO THE SHAFT. ON 16MAR2016 DEFECTIVE DEVICE RETURNED TO THE SUPPLIER FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    FINAL EVALUATION OF THE RETURNED DEVICE CONCLUDED THAT A MANUFACTURING STEP WAS MISSED. THIS DEFECT IS NOT LIKELY TO CAUSE A SERIOUS ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 QIAGEN RECEIVED A REPORT, (B)(4), FROM (B)(6) WHERE THE BRUSH HEAD BECAME DETACHED FROM THE SHAFT AND REMAINED INSIDE THE PATIENT'S CERVIX. DUE TO THE PATIENT'S NARROW CERVIX, THE DOCTOR COULD NOT EASILY REMOVE THE BRUSH WITH FORCEPS. TWO DAYS LATER THE BRUSH WAS REMOVED FROM THE PATIENT UNDER ANESTHESIA WITHOUT CAUSING INJURY.

    Description of Event or Problem · 1

    ON 24FEB2016 QIAGEN RECEIVED A REPORT, (B)(4), FROM (B)(6) WHERE THE BRUSH HEAD BECAME DETACHED FROM THE SHAFT AND REMAINED INSIDE THE PATIENT'S CERVIX. DUE TO THE PATIENT'S NARROW CERVIX, THE DOCTOR COULD NOT EASILY REMOVE THE BRUSH WITH FORCEPS. TWO DAYS LATER THE BRUSH WAS REMOVED FROM THE PATIENT UNDER ANESTHESIA WITHOUT CAUSING INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178841 DIGENE HC2 DNA COLLECTION DEVICE DIGENE HC2 DNA COLLECTION DEVICE HHT QIAGEN 170407

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR