MAUDE Adverse Event Report: QIAGEN DIGENE HC2 DNA COLLECTION DEVICE

Catalog Number 619204

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2016

Event Type  malfunction  

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 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
• Type of Device: DIGENE HC2 DNA COLLECTION DEVICE
• Manufacturer (Section D): QIAGEN; 19300 germantown road; germantown MD 20874
• Manufacturer (Section G): QIAGEN; 19300 germantown road; germantown MD 20874
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 5976768
• MDR Text Key: 55619739
• Report Number: 1122376-2016-00014
• Device Sequence Number: 1
• Product Code: HHT
• UDI-Device Identifier: 14053228010354
• UDI-Public: 14053228010354
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: 619204
• Device Lot Number: M1995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR