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

Model Number	81-080416
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the balloon deflated on its own and came out of the patient.The rn tested the balloon, and it looked like it had a hole in it." deroyal industries, inc.Requested return of the device but it has not yet been received.A supplier corrective action request (scar) has been issued to the supplier.This investigation is ongoing and not complete at this time.No further information is available at this time.We will provide follow-up information when it becomes available.
Event or Problem Description
A user facility reported, "the balloon deflated on its own and came out of the patient.The rn tested the balloon, and it looked like it had a hole in it.".
Additional Manufacturer Narrative
A user facility reported, "the balloon deflated on its own and came out of the patient.The rn tested the balloon, and it looked like it had a hole in it." deroyal industries, inc.Requested return of the device and received it on 7/16/2025.Deroyal reviewed the work order for the lot and found no issues.An inventory check was also performed on 100 eaches and all were found to be acceptable.The risk analysis was also reviewed and found to be up to date and in no need of updates.A complaint to sales analysis was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) has been issued to the supplier, xeridiem.The supplier confirmed the balloon tear on the foley catheter.The device history record (dhr) for the lot was then reviewed.All line clearance, material verification, and qc inspections were performed by trained xeridiem staff.The product was found to be manufactured in accordance with the approved part specifications.Based on the dhr review and review of the device itself, no abnormalities were identified that could have lead to the balloon tear observed.Xeridiem controls include training and certification of all production personnel and qc inspectors.Line clearances are performed and documented at each workstation.All molds, presses, and testing equipment used to manufacture the product line are documented within device history records and cleared/ calibrated when applicable.Control surrounding the actual silicone material used included stringent storage, milling, cleaning, and extrusion rules.Detailed dhr pictorial instructions are present at each workstation and deliver specific guidance for every step of the manufacturing process.Root cause: because no issues could be found within the dhr or identified based upon the device, the root cause was unable to be determined.Corrective and preventive actions: because the root cause could not be confirmed, 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 information if it 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 ; 8653622106
• MDR Report Key: 22411051
• Report Number: 2320762-2025-00010
• Device Sequence Number: 9664834
• Product Code: EYC
• UDI-Device Identifier: 00749756045766
• UDI-Public: 00749756045766
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 81-080416
• Device Lot Number: 60714161
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 12/22/2025
• 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