MAUDE Adverse Event Report: COOK INC URETERAL DILATOR; KOE DILATOR, URETHRAL

Catalog Number	076010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 during incoming inspection of the ureteral dilator, an unidentified green foreign matter in the package was found.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, manufacturing instructions, and quality control data.One unopened package labeled with part number 076010 and lot number 8313711 was received for investigation.A visual examination of the sealed package confirms green foreign matter free floating inside the package.The packaged device was returned unopened and a visual inspection identified green foreign matter free floating inside the package.The dilator and the foreign matter are the same color.Both ends of the dilator were inspected and appeared free from defects indicating the material likely did not separate during shipping.A review of the device history record found no other non-conformances associated with the complaint device lot number.A search of complaint records revealed this is the only complaint associated with lot number 8313711.This complaint is confirmed based on the returned device.The cause has been traced to manufacturing; a quality control deficiency.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is warranted.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
There has been no new information received since the last report was submitted.

• Brand Name: URETERAL DILATOR
• Common Device Name: KOE DILATOR, URETHRAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7898828
• Report Number: 1820334-2018-02830
• Device Sequence Number: 19245835
• Product Code: KOE
• UDI-Device Identifier: 00827002143005
• UDI-Public: (01)00827002143005(17)201023(10)8313711
• Combination Product (Y/N): N
• PMA/510(K) Number: K810371
• 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): 10/30/2018

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: 10/23/2020
• Device Catalogue Number: 076010
• Device Lot Number: 8313711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1