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

Model Number	G15942
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, "dirt" was discovered in the sterilization package of an open-end ureteral catheter.The issue was discovered by a nurse in the operating room, prior to the device being opened.No adverse events have been reported.
Additional Manufacturer Narrative
(b)(6).Customer occupation = unknown.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 or Problem Description
Additional information was received 23nov2022.The issue was discovered as the device was delivered to the user facility.The device was not involved in any procedure.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5 h3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, "dirt" was discovered in the sterilization package of an open-end ureteral catheter.The issue was discovered by a nurse in the operating room, prior to the device being opened.The issue was discovered as the device was delivered to the user facility.The device was not involved in any procedure.No adverse events have been reported.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection was also conducted.One unopened package was returned labelled with the same lot number as the complaint device.A visual inspection noted a brown stain on inside of the tyvek of the packaging.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.The product ifu provides the following information: how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.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 the field.A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that the cause for the brown stain cannot be established, its not possible to rule out shipping.Tyvek is a breathable material that is design to allow vapors through but resists bulk water and air penetration.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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
• 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: 15813349
• Report Number: 1820334-2022-01739
• Device Sequence Number: 12094424
• Product Code: KOD
• UDI-Device Identifier: 00827002159426
• UDI-Public: (01)00827002159426(17)250830(10)14934754
• Combination Product (Y/N): N
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2023

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 Expiration Date: 08/30/2025
• Device Model Number: G15942
• Device Catalogue Number: 020040-C6
• Device Lot Number: 14934754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 12/30/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/20/2022; 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown