MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G14637
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: pre-amendment.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
It was reported that there was a red string particle type fiber inside the c-flex double pigtail ureteral stent set packaging.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation evaluation: a visual examination of the returned device was conducted.A review of complaint history, the device history record, manufacturing instructions, and specifications was also performed.One unopened package labeled rpn 036310 with label lot number 8772944 was received.Visual examination confirmed brown foreign matter similar to cardboard is trapped inside the sealed package.Based on the evidence presented by the sample, this event has been attributed to a packaging event.A review of the device history record found there are no non-conformances associated with the complaint device lot number.A review of complaint history for this product/lot number combination revealed this is the only complaint associated with lot number 8772944.The cause for the reported issue is manufacturing related.Measures have been initiated to address this issue.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7552789
• Report Number: 1820334-2018-01541
• Device Sequence Number: 176961
• Product Code: FAD
• UDI-Device Identifier: 00827002146372
• UDI-Public: (01)00827002146372(17)210413(10)8772944
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: No Information
• Device Model Number: G14637
• Device Catalogue Number: 036310
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1