MAUDE Adverse Event Report: QIAGEN DIGENE HC2 DNA COLLECTION DEVICE

Catalog Number 5122-1220

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/23/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 incident reported to qiagen technical service.On (b)(4) 2015 incident date and details and defective device required.On (b)(4) 2015 customer reported the incident occurred.On (b)(6) 2015 and device was removed and discarded by physician same day.No other devices from the same box had this defect.On (b)(4) 2015 complaint history review found no prior complaints for this lot.On (b)(4) 2015 device history review found kit lot 170407 contained cervical brush (a0040) lots bscb41i and bscb42i.Both brush lots passed torque test qc specifications.On (b)(4) 2015 supplier notified of incident.

Event Description

On (b)(6) 2015, qiagen received a report from (b)(6), (b)(4), where a brush head detached from the shaft while collecting sample from patient.The physician removed and discarded the device before reporting the incident to qiagen.In an abundance of caution, this incident is being reported now because a similar complaint for the same lot was reported (b)(4) that required medical intervention for removal although there was no injury to the patient.

• 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: 5525064
• MDR Text Key: 41123120
• Report Number: 1122376-2016-00011
• Device Sequence Number: 1
• Product Code: HHT
• 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: Other
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/08/2017
• Device Catalogue Number: 5122-1220
• Device Lot Number: 170407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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