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

Catalog Number	028518-OE
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k091767.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 the patient removed and discarded their universal silicone foley catheter days after it was changed at the clinic due to the balloon deflating.A replacement suprapubic catheter was placed in the bladder with no reported issues.There were no adverse consequences to the patient as a result of this reported issue.
Additional Manufacturer Narrative
Investigation, evaluation: the universa silicone foley catheter has not been returned for an evaluation and no photographs were provided for review.A review of complaint history, the device history record, the instructions for use, quality control data and specifications was conducted.Devices from the same lot in stock at the cook distribution center were retrieved for the investigation.No anomalies were observed with these unused units.Three of the units were tested.The three devices were inflated with 5ml of water (as indicated in labeling) and left for 24 hours inside a closed dark cardboard box.The three balloons were deflated and re-inflated with 5ml water and left again for another 24 hours.No leaks were noted during either 24-hour period and the balloons remained inflated during the test periods.A review of the device history record showed no non-conformances associated with the complaint device lot number.A review for additional complaints related to this device lot revealed no other complaints associated with the complaint device lot number 7991491.The instructions for use supplied with this device contains the following references: ureteral insertion: ensure the catheter is well lubricated then pass the deflated catheter through the urethra and into the bladder.An open-ended catheter may be introduced over a well lubricated wire guide to facilitate placement.Once position is confirmed (via flow of urine or aspiration of urine, if necessary), connect a syringe containing sterile media to the luer of the inflation lumen on the two- or three-pronged y-fitting.Use the syringe to fill the balloon.It is recommended the balloon's fluid volume be checked periodically and then re-inflated with recommended volume." suprapubic placement: ensure the catheter is well lubricated then pass the deflated catheter through the urethra and into the bladder.An open-ended catheter may be introduced over a well lubricated wire guide to facilitate placement.Once position is confirmed (via flow of urine or aspiration of urine, if necessary), connect a syringe containing sterile media to the luer of the inflation lumen on the two- or three-pronged y-fitting.Use the syringe to fill the balloon.It is recommended the balloon's fluid volume be checked periodically and then re-inflated with recommended volume.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a likely cause for the alleged balloon deflation cannot be established.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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
The patient lost the ability to drain their bladder until a new foley was placed.

• 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: 7377045
• Report Number: 1820334-2018-00476
• Device Sequence Number: 1482703
• Product Code: EZL
• UDI-Device Identifier: 00827002175129
• UDI-Public: (01)00827002175129(17)200430(10)7991491
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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 Catalogue Number: 028518-OE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1