MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER

Model Number 81-080416EU

Device Problems Decrease in Suction (1146); Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; therefore we were not able to complete a thorough investigation.A supplier corrective action request (scar) has been sent to vendor in relation to the product issue; however, still waiting for completion.The investigation is incomplete at this time, a follow-up report will be submitted with additional information once received, this report will be updated.

Event Description

Unable to withdraw remaining fluid from the catheter.More fluid could be inserted into the balloon but not removed.Balloon remained inflated when withdrawn.

Manufacturer Narrative

A scar was completed by the supplier; however, no root cause was established due to device not being returned for supplier evaluation.Photos provided with the complaint showed the balloon was still inflated; however, without the ability to investigate the device itself.Per the supplier (xeridiem), "potential causes for the balloon to remain inflated after attempt include shipping, storage, maintenance, and liquid used to inflate the balloon.Hospitals may use saline to inflate the balloon rather than water which can cause crystallization of the saline within the inflation lumen." xeridiem examined the device history records for manufacturing lot #1011026103 and found no complaints related to similar failures.Deroyal has sold (b)(4) cases of finished goods of 81-080416eu in the past two years with no similar complaints.The investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; 602 parkway, la aurora; new tazewell TN 37825
• MDR Report Key: 11821153
• MDR Text Key: 250740320
• Report Number: 2320762-2021-00001
• Device Sequence Number: 1
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (y/n): N
• PMA/PMN Number: K200757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-080416EU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1