MAUDE Adverse Event Report: QIAGEN CAREBRUSH

Catalog Number 619024

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

The device was being used in (b)(6) as part of a customer's study for self sample collection.The currently marketed intended use for carebrush is to be used by physicians and trained medical professionals for the collection of cervical specimens for subsequent testing of the (b)(6) test.Several attempts were made to follow up with the reporting facility to obtain further details around this incident.The reporting facility was unable to provide further details.Similar complaints have been reported for this brush.Prior investigation concluded that the device malfunction was due to the brush missing the heating process which adheres it to the stem.There have been a total of 5 complaints for detached brush tips reported since this device has been in distribution (1997).Over (b)(4) brushes have been distributed.(b)(4).This defect is not likely to cause an adverse event and the probability of this defect requiring medical or surgical intervention is remote.This product is not approved or distributed in the us, however the brush is substantially similar to the digene hc2 dna collection device that is approved in the us.Device was not returned for evaluation.

Event Description

On 13apr2016 qiagen received a report, (b)(4), from (b)(6) of an incident where the brush head became detached from the shaft and remained inside the end user.The nursing assistant examined the end user and could not locate the brush.Two days later the end user returned to the health facility and informed them that the brush was expulsed and no injuries were incurred.

• Brand Name: CAREBRUSH
• Type of Device: CAREBRUSH
• 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: 5652832
• MDR Text Key: 45136139
• Report Number: 1122376-2016-00012
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 619024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 25 YR