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

Catalog Number 028518-OE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

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 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.

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 Description

The patient lost the ability to drain their bladder until a new foley was placed.

• Brand Name: UNIVERSA SILICONE FOLEY CATHETER
• Type of Device: EZL CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377045
• MDR Text Key: 103749260
• Report Number: 1820334-2018-00476
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00827002175129
• UDI-Public: (01)00827002175129(17)200430(10)7991491
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 028518-OE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1