MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; KOD CATHETER, UROLOGICAL

Model Number	G14818
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer name and address 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 or Problem Description
As reported, an open-end ureteral catheter separated in a patient's ureter.Additional information regarding the event and patient outcome have been requested.
Event or Problem Description
The information reported in the initial report was noted to have occurred during the same case with the same lot as reported in patient reference (b)(6) (mdr report reference number 1820334-2021-01268).
Additional Manufacturer Narrative
Corrected information: b1, b5, h1: no product malfunction, serious injury, or death occurred related to this mdr.This report is a duplicate of mdr report reference number 1820334-2021-01268.A follow-up report will be submitted on mdr report reference number 1820334-2021-01268, upon receipt of additional information or completion of the investigation.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: OPEN-END URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11759494
• Report Number: 1820334-2021-01267
• Device Sequence Number: 3142717
• Product Code: KOD
• UDI-Device Identifier: 00827002148185
• UDI-Public: (01)00827002148185(17)240128(10)13722291
• Combination Product (Y/N): N
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 01/28/2024
• Device Model Number: G14818
• Device Catalogue Number: 020013
• Device Lot Number: 13722291
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1