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

Model Number	81-080408
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the foley is tested, works, placed in patient and then no longer works".Deroyal industries requested return of the device but it has not yet been received.A supplier corrective action request (scar) has been sent to the supplier.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, "the foley is tested, works, placed in patient and then no longer works".
Additional Manufacturer Narrative
A user facility reported, "the foley is tested, works, placed in patient and then no longer works".Deroyal industries requested return of the device and received it 2/20/2025.Deroyal industries tested several foley devices found that when issues with resistance were occurring it was often found that the cables were not correctly attached to the pin causes performance issues.It was also noted in testing that bending of the cable can cause performance issues.It was confirmed that after bending the cables, all cable with performance issues was found to have the cable separated from the pin.It was noted that each of the wire sets is 100% inspected and fully detected within the manufacturing and inspection processes.Because the wire is very delicate, if it is not handled correctly, it can become detached from the pin.Following the wire set manufacturing and 100% inspection, the wire set is sent to the supplier, spectrum plastics, to have the foley molded around it.There is a chance that this malfunction could occur during spectrum's molding process, however that has not been confirmed.Inventory from 3 different lots were inspected.All (b)(6) eaches were found to be within specification and acceptable.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 sent to the supplier.Spectrum reviewed manufacturing processes, inspections, work instructions, and line clearances.All were found to be acceptable and within specifications.No issues could be identified within manufacturing.Root cause: while the malfunction was able to be repeated, no issues could be found within manufacturing and therefore the cause of the malfunction was unable to be determined.Potential root cause: manufacturing of the wire sets is 100% inspected for performance prior to shipping to the supplier.With that information and the fact that the pin is delicate in nature, there is a potential that a separation between the pin and cable is occurring during the suppliers molding of the foley onto the wire set.Corrective and preventive actions: because the root cause could not be determined, no corrective or preventive actions have been 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 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21425966
• Report Number: 2320762-2025-00001
• Device Sequence Number: 12703621
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 81-080408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 08/08/2025
• 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