MAUDE Adverse Event Report: COOK INC UNIVERSA SILICONE FOLEY CATHETER; EZL CATHETER, RETENTION TYPE, BALLOON

Catalog Number	028506-OE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The 510k: k091767.(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 the hypospadias repair procedure, the universa silicone foley catheter was inserted on (b)(6) 2018 around 12 noon and at 9 pm the foley catheter came out and balloon was deflated.The patient had another foley catheter placed.No other adverse patient consequences were reported.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, and quality control data.Function testing determined the balloon inflated without issue.There were no leaks in the balloon material.During deflation of the balloon the inflation valve separated from the hub.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for complaint device lot number 8333411.Instructions for use (ifu) provides the following precaution: visually inspect the product for any imperfections or surface deterioration prior to use.A functional test determined the returned foley catheter inflated without issue.During deflation of the balloon, the inflation valve separated from the hub.The cause of inflation valve separation could not be determined.It is possible excessive force applied to the inflation valve caused separation, leakage, and deflation of the balloon.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause for this specific failure mode could not be established.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and 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.
Event or Problem Description
Additional information received states that the balloon was filled with 1.5ml(cc) of liquid for placement.There were no medical illnesses or adverse effects related to this incident.

• Brand Name: UNIVERSA SILICONE FOLEY CATHETER
• Common Device Name: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7905662
• Report Number: 1820334-2018-02832
• Device Sequence Number: 13859264
• Product Code: EZL
• UDI-Device Identifier: 00827002172036
• UDI-Public: (01)00827002172036(17)191231(10)8333411
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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: 12/31/2019
• Device Catalogue Number: 028506-OE
• Device Lot Number: 8333411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASKU
• Patient Age: 14 MO
• Patient Weight: 9