MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 14 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080414
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "there was no urine output for 6 hours after lasix administration.Noted palpable bladder and bladder scan was done.Foley catheter was changed and 1100ml of urine was drained." deroyal industries inc., requested return of the device, but it has not yet been received.A supplier corrective action request has been issues to the supplier.This investigation is ongoing and 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, "there was no urine output for 6 hours after lasix administration.Noted palpable bladder and bladder scan was done.Foley catheter was changed and 1100ml of urine was drained.".
Additional Manufacturer Narrative
A user facility reported, "there was no urine output for 6 hours after lasix administration.Noted palpable bladder and bladder scan was done.Foley catheter was changed and 1100ml of urine was drained." deroyal industries inc., requested return of the device and it was received on 10/30/2025 to then be sent to the supplier.Deroyal reviewed the work order and found no issues or discrepancies.An inventory check was performed on 100 each of the finished goods and 100 each of the raw materials and all were found to be within specification and acceptable.A complaint to sales ratio was conducted over the past two years and found to be 0.006%.A supplier corrective action request has been issues to the supplier, (b)(4).Xeridiem reviewed the returned samples from the same lot and conducted functionality testing.35cc's of water was run withdrawn through the lumen 5 times on each device.Each time the water was successfully extracted and no blockages or obstructions were observed.Device history record for the lot was also reviewed.No deviations or issues were found.All product was found to be manufactured in accordance with approved part specifications.Root cause: because no blockages or obstructions could be observed in the returned devices nor were any issues found within the manufacturing review, the root cause could not be determined.Corrective and preventive action: because no root cause could 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: FOLEY CATHETER, 400 SERIES 14 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: 22411050
• Report Number: 2320762-2025-00008
• Device Sequence Number: 18558040
• Product Code: EYC
• UDI-Device Identifier: 50749756045778
• UDI-Public: 50749756045778
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 81-080414
• Device Lot Number: 61357097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 02/25/2026
• 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