MAUDE Adverse Event Report: COOK INC AQ HYDROPHILIC COATED DILATOR; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that, upon opening the aq hydrophilic coated dilator, an unknown powder was discovered on the product.As a result, the device was subsequently not used during the insertion of the nephrostomy catheter procedure.The customer confirmed that there was no patient contact; accordingly no patient adverse events resulted from the product problem.The device has been received for evaluation, but the investigation is still pending as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control data, specifications, and visual inspection/ dimensional verification of the device was conducted during the investigation.Physical examination of the complaint device confirms that coating appeared slightly white in color near the proximal end of the coating length, and near the center of the coated portion.Coating felt rough in these areas.Coating length was within specification and no substance rubbed off of the device when the device was felt with gloves.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.A review of the device history record showed no nonconforming events for lot 807395.Also, it should be noted there were no other reported complaints for this lot number.The dilator was returned and was found to have a small white discoloration on the surface.No retraining was necessary as it is unknown if the speck was an inconsistence in coating or damage obtained from shipping or handling of the device.The root cause was found to be inconclusive.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: AQ HYDROPHILIC COATED DILATOR
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7280468
• Report Number: 1820334-2018-00364
• Device Sequence Number: 19168075
• Product Code: DRE
• UDI-Device Identifier: 00827002102071
• UDI-Public: (01)00827002102071(17)200717(10)8070395
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: JCD10.0-38-20-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/17/2018; 04/20/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 04/19/2018; 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1