MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD STENT, URETERAL

Catalog Number 025806-S1-JP

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

E1- postal code: (b)(6).D4 -catalog number: device is not marketed in the united states.There are similar devices marketed in the united states, for example catalog number 025806-s1.Information for 025806-s1: d2a - common device name: fad stent, ureteral, d2b -pro code: fad, g4 pma/510(k) #: k181971.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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

It was reported that a foreign body was found in the package of a bander ureteral diversion stent set by the distributor.There was no patient contact.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17603876
• MDR Text Key: 321749244
• Report Number: 1820334-2023-01100
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002575813
• UDI-Public: (01)00827002575813(17)260224(10)15241262
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2023

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 Catalogue Number: 025806-S1-JP
• Device Lot Number: 15241262
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1