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

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2018

Event Type  malfunction  

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 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.

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.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, manufacturing instructions, quality control data, specifications, and visual inspection of the device was conducted during the investigation.Physical examination of the complaint device confirms we received one opened dilator back for investigation.A small white dot was observed on the device within the coated area.The small dot appears to be an inconsistency in coating or drying process, or potentially the device was slightly nicked on an object when removed from package.The coating appears smooth without water testing.In addition, the coated length was within the allowed parameters.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 nonconformances associated with lot 8032957.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 speck on the surface.No retraining was necessary as it is unknown if the speck was an inconsistence in coating or damage obtain 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 h3 other text : blank fields on this form indicate the information is previously submitted, unknown, or unavailable investigation ¿ evaluation.A review of the complaint history, device history record, drawing, manufacturing instructions, quality control data, specifications, and visual inspection of the device was conducted during the investigation.Physical examination of the complaint device confirms we received one opened dilator back for investigation.A small white dot was observed on the device within the coated area.The small dot appears to be an inconsistency in coating or drying process, or potentially the device was slightly nicked on an object when removed from package.The coating appears smooth without water testing.In addition, the coated length was within the allowed parameters.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 nonconformances associated with lot 8032957.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 speck on the surface.No retraining was necessary as it is unknown if the speck was an inconsistence in coating or damage obtain 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.

• Brand Name: AQ HYDROPHILIC COATED DILATOR
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7280202
• MDR Text Key: 100537915
• Report Number: 1820334-2018-00363
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00827002102897
• UDI-Public: (01)00827002102897(17)200630(10)8032957
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: JCD8.0-38-20-HC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1