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

Model Number	G49981
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The area representative reported the universa soft ureteral stent was observed to be discolored in the package prior to opening.The stent was not used.No additional procedures were required due to this occurrence.There were no adverse effects or consequences to the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection of the returned devices, a review of complaint history, the device history record, quality control data, and the device specifications.Two unopened packages labeled rpn ush-724-r with label lot number 7299025 were received.The outer storage boxes were not returned.The stents in both packages were noted to have some yellow discoloration on areas that were not covered by the label.Slight discoloration was observed on the proximal coil of both stents.Discoloration extended up to the first ink band 6cm from the proximal end.Discoloration could not be wiped off during examination.No other discoloration was observed on the stent.A review of the device history record showed there were no non-conformances associated with the complaint device lot number.A review of complaint history revealed this is the only complaint that has been received associated with the complaint device lot number 7299025.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.The supplier of the raw material tubing for this product investigated the complaint.They reviewed their lot records for the raw material and process for the tubing manufacture and found no anomalies.They identified that one of the raw materials used in the tubing to give it its radiopaque characteristic reacts to light by turning a yellowish/brownish color.Based on the information from the supplier of the tubing used in the stent, light exposure during shipping or storage of the finished product could have contributed to this complaint.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6917308
• Report Number: 1820334-2017-03508
• Device Sequence Number: 1181635
• Product Code: FAD
• UDI-Device Identifier: 10827002499819
• UDI-Public: (01)10827002499819(17)190923(10)7299025
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

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: G49981
• Device Catalogue Number: USH-724-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1