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

Catalog Number	020015
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = inventory control coordinator.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
As reported, when pulling an 'open-end ureteral catheter' from the stockroom, a hair-like matter was found inside of the unopened package.Another 'open-end ureteral catheter' was used to complete the procedure.There was no patient involvement or contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, when pulling an 'open-end ureteral catheter' from the stockroom, a hair-like matter was found inside of the unopened package.Another 'open-end ureteral catheter' was used to complete the procedure.There was no patient involvement or contact.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found one related non-conformance reported for lot 15390116 for 'loose material' that was similar to the reported failure mode; however, the non conforming product was scrapped prior to lot release.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device for lot 15390116.Due to the individual nature of inspecting the finished package product, one non conformance 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 non conforming product are in the field; however, this lot will continue to be monitored.Cook also reviewed product labeling.The ifu [t_urecat_rev1; 'ureteral catheters'] supplied with the device states the following in consideration of the reported failure mode: '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." visual inspection of the returned complaint device was also conducted.One 'open-end ureteral catheter' was returned for investigation in unopened packaging.A short black hair was noted near the seam inside the packaging; the complaint was confirmed.The complaint was confirmed based on the device failure analysis.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint is manufacturing related.The employees who inspected the finished packaged product have been made aware of the non conformance.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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.

• 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: 17470842
• Report Number: 1820334-2023-01038
• Device Sequence Number: 12635751
• Product Code: KOD
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)260414(10)15390116
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2026
• Device Catalogue Number: 020015
• Device Lot Number: 15390116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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