MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL FOLEY CATHETER, 400 SERIES 8 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080408
Medical Device Problem Codes	Failure to Sense (1559); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported via medwatch, "foley temperature probe wire exposed.Temperature function no longer used.Foley still in patient, believed to be 8fr." deroyal industries, inc.Requested return of the device, but it was not available for return.A supplier corrective action request (scar) will be sent to the supplier, spectrum plastics.This investigation is not complete at this time.No further information is available at this time.We will provide follow up report when additional information becomes available.
Event or Problem Description
A user facility reported on a medwatch, "foley temperature probe wire exposed.Temperature function no longer used.Foley still in patient, believed to be 8fr.".
Additional Manufacturer Narrative
A user facility reported via medwatch, "foley temperature probe wire exposed.Temperature function no longer used.Foley still in patient, believed to be 8fr." deroyal industries, inc.Requested return of the device, but it was not available for return.The device history record was reviewed and no issues were found.Functional testing and visual inspection results were reviewed for the referenced lots and no discrepancies were identified.An inventory check was performed on a case of product from a different lot.No defective product was identified with inspection.A complaint to sales ratio was conducted over the past two years and found to be 0.074%.A supplier corrective action request (scar) will be sent to the supplier, spectrum plastics.The device history record of the supplier was reviewed.5 units were scrapped due to damage to the sensor during insertion, but no discrepancies were noted.Root cause: because the sample could not be returned and no issues were identified during the manufacturing inspections, the root cause was unable to 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.This 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: DEROYAL FOLEY CATHETER, 400 SERIES 8 FR
• 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: 22786248
• Report Number: 2320762-2025-00014
• Device Sequence Number: 9869441
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K041416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81-080408
• Device Lot Number: 619446799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown