MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49945

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported by an international distributor that a package for a universa soft ureteral stent set had a particle inside of it.The device did not make it to a user facility, therefore it did not have patient contact.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported by an international distributor that a package for a universa soft ureteral stent set had a particle inside of it.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, and specifications.One device was returned for investigation.Visual examination of the unopen package confirmed a hair like foreign matter, dark in color was inside the sealed package.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that 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.A review of employee training records for the device found the employee who performed the particulate inspection has been trained to the inspection procedure.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Visual examination of the unopened complaint device that was returned confirmed the presence of the foreign matter in the device packaging.The cause for this occurrence is attributed to the foreign matter not being identified during the quality control inspection of packaged devices prior to distribution.Due to the individual nature of inspecting product packaging for foreign matter during manufacturing, one nonconformance does not indicate additional non conformances in the lot.Additionally, there have been no other complaints filed for this lot.Therefore, there is no evidence to suggest that nonconforming product are in the field; however, this lot will continue to be monitored.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Per the quality engineering risk assessment, no further action is warranted.Cook 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.

Event Description

No new patient or event information to report.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9852886
• MDR Text Key: 184136678
• Report Number: 1820334-2020-00647
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)230121(10)NS10279547
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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
• Device Operator: No Information
• Device Expiration Date: 01/21/2023
• Device Model Number: G49945
• Device Catalogue Number: USH-600
• Device Lot Number: NS10279547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1