MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15144
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: pre-amendment.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, while putting away stock and prior to opening the package for a filiform double pigtail ureteral stent set, a hair was discovered in the sealed perimeter of the packaging.There was no use on patients.No adverse effects have been reported due to the alleged malfunction.
Event or Problem Description
No new patient or event information since the last report was submitted on 08oct2019.
Additional Manufacturer Narrative
Investigation evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Visual examination of the unopened package confirmed a hair-like fiber sealed inside of the packaging.A review of the device history record found no non-conformances.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The complaint was confirmed based on customer testimony and analysis of the returned device.The complaint device was determined to be out of specification.Due to the individual nature of inspecting finished products for foreign matter one nonconformance does not indicate additional non conformances in the lot.Additionally, there have been no other complaints filed for this lot.It was concluded, the cause was traced to manufacturing and quality control deficiency.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: FILIFORM 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: 9167694
• Report Number: 1820334-2019-02552
• Device Sequence Number: 19282966
• Product Code: FAD
• UDI-Device Identifier: 00827002151444
• UDI-Public: (01)00827002151444(17)211127(10)9335462
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Expiration Date: 11/27/2021
• Device Model Number: G15144
• Device Catalogue Number: 133622
• Device Lot Number: 9335462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1