MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 14 FR (+/-0.1C); CATHETER, UPPER URINARY TRACT

Model Number	81-080414EU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "catheter balloon leaks and deflates near bag connection point." the distributed followed up and stated no injuries or outcomes were reported.
Additional Manufacturer Narrative
A distributing facility reported, "catheter balloon leaks and deflates near bag connection point." the distributed followed up and stated no injuries or outcomes were reported.Deroyal industries, inc.Has requested return of the device but it has not yet been received.A supplier corrective action request (scar) has been issued to the supplier, (b)(4).The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Additional Manufacturer Narrative
A distributing facility reported, "catheter balloon leaks and deflates near bag connection point." the distributed followed up and stated no injuries or outcomes were reported.Deroyal industries, inc.Has requested return of the device and it was received on 8/18/2025 and sent to the supplier for evaluation.Deroyal reviewed the work order and no discrepancies were found.Inventory of 200 raw materials was inspected and no issues were found by visual inspection.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) has been issued to the supplier, spectrum plastics.Spectrum inspected the returned device and confirmed the balloon tear, however, the exact cause could not be determined based upon the returned sample.The device history record for the lot of the returned product was inspected and no issues were found as all products were found to be within specifications.Spectrum conducts multiple inspections throughout the manufacturing process to identify defects and ensure product integrity and quality.Current controls include training and certification of all production personnel and qc inspectors.Line clearances are performed and documented at each workstation.All molds, presses and testing equipment used to manufacture the product line are documented within the device history record and cleaned/ calibrated when applicable.Control surrounding the actual silicone material used include stringent storage, milling, cleaning.And extrusion rules.Detailed dhr/pic (pictorial instructions) are present at each workstation and deliver specific guidance for every step of the manufacturing process.Each balloon undergoes a 100% inflation test as part of the quality assurance process.The balloon is inflated and maintained in the inflated state for approximately 10 minutes.During this period, any defects such as leaks, structural weakness, or material inconsistencies are identified.There are potential external factors that could contribute to a balloon tear such as mechanical stress from overinflation due to inappropriate syringe use or other factors such as temperature extremes and poor placement techniques.Root cause: because the exact root cause couldn't be determined by the sample and no manufacturing issues could be found within the manufacturing records, the exact root cause could not be determined.Corrective and preventive actions: because the root cause could not be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.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, 400 SERIES 14 FR (+/-0.1C)
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22629928
• Report Number: 2320762-2025-00012
• Device Sequence Number: 8155379
• Product Code: EYC
• UDI-Device Identifier: 00749756596657
• UDI-Public: 00749756596657
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 81-080414EU
• Device Lot Number: 61490947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown