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

Model Number	G15944
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: purchaser.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
It was reported that upon inspection of the packaging of a open-end ureteral catheter a hair was found inside.It is unknown when this was found, either during product intake at the user facility or before a case with a patient.Although, the event was reported to have occurred at the distributor.No adverse effects were reported.Additional information has been requested.
Event or Problem Description
Additional information was received 04aug2020: the hair in the package was discovered when the device was received at our distributors warehouse.
Additional Manufacturer Narrative
Investigation / evaluation: it was reported, when the open-end ureteral catheter was received at our distributors warehouse, the staff noticed a hair inside the packaging.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, specifications, the instructions for use, and quality control data.One unopened package containing a open-end ureteral catheter was returned for investigation.A visual examination of the unopened package confirmed a hair like fiber loose and sealed inside the package.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 complaints associated with the complaint device lot.Due to the individual nature of inspecting finished product for foreign matter, one nonconformance 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 that nonconforming product are in the field; however, this lot will continue to be monitored.A review of the product labeling found no information for the end users related to this failure mode.The returned unopened package confirmed a hair like fiber loose and sealed inside the package.A review of production processes found quality controls to be in place including an inspection of all finished products for foreign matter.The cause of the complaint is manufacturing related.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.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: 10200169
• Report Number: 1820334-2020-01203
• Device Sequence Number: 11024247
• Product Code: KOD
• UDI-Device Identifier: 00827002159440
• UDI-Public: (01)00827002159440(17)230210(10)10318783
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: No Information
• Device Expiration Date: 02/10/2023
• Device Model Number: G15944
• Device Catalogue Number: 020040-C5
• Device Lot Number: 10318783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1