MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL FOLEY CATHETER, 400 SERIES 10 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080410
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
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 through a medwatch (# (b)(4)), "the temperature probe functioning upon insertion [date redacted].On [date redacted]: the next day, it began to intermittently read incorrectly, going from 37.0 to 11.4 and bouncing around, then reading steady.Temperature probe completely stopped working on [date redacted]: the second day." deroyal industries, inc.Requested return of the device, but it was not available for return.A supplier corrective action request (scar) will be issued 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 through a medwatch (# (b)(4)), "the temperature probe functioning upon insertion [date redacted].On [date redacted]: the next day, it began to intermittently read incorrectly, going from 37.0 to 11.4 and bouncing around, then reading steady.Temperature probe completely stopped working on [date redacted]: the second day.".
Additional Manufacturer Narrative
A user facility reported through a medwatch ((b)(4)), "the temperature probe functioning upon insertion [date redacted].On [date redacted] - the next day, it began to intermittently read incorrectly, going from 37.0 to 11.4 and bouncing around, then reading steady.Temperature probe completely stopped working on [date redacted] - the second day." deroyal industries, inc.Requested return of the device, but it was not available for return.As this was discovered to be part of the connector, no supplier corrective action request was required to be sent to the supplier.As the lot was not reported, the specific device history record (dhr) was not able to be reviewed.An inventory check was not performed as this reported complaint was not something that could be discovered with visual inspection.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).Root cause: because the sample was not returned and the lot number was not provided, the root cause could not be determined.Corrective 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: DEROYAL FOLEY CATHETER, 400 SERIES 10 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: 22852914
• Report Number: 2320762-2025-00015
• Device Sequence Number: 8457876
• Product Code: EYC
• UDI-Device Identifier: 00749756045797
• UDI-Public: 00749756045797
• 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): 03/16/2026

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: 81-080410
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 03/16/2026
• 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
• Patient Sex: Unknown