MAUDE Adverse Event Report: QIAGEN DIGENE HC2 DNA COLLECTION DEVICE

Catalog Number	619204
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: DIGENE HC2 DNA COLLECTION DEVICE
• Common Device Name: DIGENE HC2 DNA COLLECTION DEVICE
• Manufacturer (Section D): QIAGEN; 19300 germantown road; germantown MD 20874
• MDR Report Key: 5976768
• Report Number: 1122376-2016-00014
• Device Sequence Number: 79954
• Product Code: HHT
• UDI-Device Identifier: 14053228010354
• UDI-Public: 14053228010354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: 619204
• Device Lot Number: M1995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR