MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 16 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080416
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "all three patients were having decrease in urine output, during assessment the uct team reviewed the cases and found that all three foley catheters were blocked.".
Additional Manufacturer Narrative
A distributing facility reported, "all three patients were having decrease in urine output, during assessment the uct team reviewed the cases and found that all three foley catheters were blocked." deroyal industries, inc.Requested return of the device, however it was stated that it was unavailable for return.A supplier corrective action request (scar) will be issued to the supplier, (b)(4).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.

• Brand Name: FOLEY CATHETER, 400 SERIES 16 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
• MDR Report Key: 25003051
• Report Number: 2320762-2026-00006
• Device Sequence Number: 9813902
• Product Code: EYC
• UDI-Device Identifier: 50749756045761
• UDI-Public: 50749756045761
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K200757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 81-080416
• 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: 04/20/2026
• Initial Report FDA Received Date: 04/27/2026
• 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