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

Model Number	81-080416EU
Medical Device Problem Codes	Decrease in Suction (1146); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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fluid from the catheter.More fluid could be inserted into the balloon but not removed.Balloon remained inflated when withdrawn.
Additional 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
• Common Device Name: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; 602 parkway, la aurora; new tazewell TN 37825
• MDR Report Key: 11821153
• Report Number: 2320762-2021-00001
• Device Sequence Number: 3767451
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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 Model Number: 81-080416EU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1