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

Catalog Number 028516-CE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

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 was fitted with a universa silicone foley catheter on the morning of (b)(6) 2018.As reported, the balloon was inflated at 5cc and found in the patient¿s garment on (b)(6) 2018.A new catheter was placed on (b)(6) 2018 and the balloon again inflated at 5cc.New information received on (b)(6) 2018, the second device also failed.It does not fit in the patient.The facility has reported the device has been discarded and will not be returned.This report is being filed on the second catheter placed on (b)(6) 2018.Manufacturer report # 1820334-2018-01319 was previously filed to capture the initial catheter placed on (b)(6) 2018.Addition information has been requested regarding failure mode and patient outcome but has not yet been received.

Manufacturer Narrative

Investigation ¿ evaluation: the universa silicone foley catheter has not been returned for an evaluation and no photographs were provided for review.Without the complaint device, a physical investigation was not able to be completed.A review of the instructions for use, quality control data and specifications was conducted.A review of the device history record was not able to be performed as the device lot number was not provided.A review for additional complaints related to this device lot could not be completed without the device lot number.The instructions for use supplied with this device contains the following warnings and precautions.Warnings: do not use petroleum-based ointments or lubricants since they may damage silicone and burst balloons.Always inflate the balloon with a sterile liquid.Never inflate with air, carbon, dioxide or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Precautions: when inflating the balloon, use a luer syringe.Do not use a needle.Should balloon rupture occur, care should be taken to ensure that all balloon fragments have been removed from the patient.How supplied = store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.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 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 definitive cause for the reported issue has not been 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.

Event Description

Additional information was obtained during follow up with the customer.The lot number is unknown.The patients include older men and women, injured persons, and persons on resuscitation who need permanent urine drainage.The complaint statement "the second foley did not fit the patient" was explained further.As described, the foley probe slipped and left the patient.It¿s really uncomfortable to disturb old or sick patients to set up a foley catheter each days, whereas we can change it by month.And it makes the care patient really unacceptable.

• 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: 7578501
• MDR Text Key: 110462130
• Report Number: 1820334-2018-01681
• Device Sequence Number: 1
• Product Code: EZL
• 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: 07/03/2018

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: 028516-CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1