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	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A distributing facility reported, "it was noticed after the surgery that the foley catheter was not in the patient, that the balloon had burst.No blood was noted.300ml of clear yellow urine was drained in the foley bag.Surgeon and anesthesiologist there were notified of the incident.Unsure if there was an injury in the urethra." deroyal industries, inc.Has requested return of the device but has not yet received it.A supplier corrective action request (scar) has been issued to the catheter supplier, spectrum plastics group.This investigation is not complete at this time.No further information is available at this time.We will provide follow up information when additional information becomes available.
Event or Problem Description
A distributing facility reported, "it was noticed after the surgery that the foley catheter was not in the patient, that the balloon had burst.No blood was noted.300ml of clear yellow urine was drained in the foley bag.Surgeon and anesthesiologist there were notified of the incident.Unsure if there was an injury in the urethra.".
Additional Manufacturer Narrative
A distributing facility reported, "it was noticed after the surgery that the foley catheter was not in the patient, that the balloon had burst.No blood was noted.300ml of clear yellow urine was drained in the foley bag.Surgeon and anesthesiologist there were notified of the incident.Unsure if there was an injury in the urethra." deroyal industries, inc.Has requested return of the device but it was not received.No lot number was provided, therefore the work order could not be reviewed.An inventory check was performed on 100 eaches and no visual issues were observed.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 issued to the catheter supplier, spectrum plastics group.Because the sample nor the lot number were available the dhr review nor lot trending could be conducted.The supplier stated, without the sample the specific cause of the balloon burst cannot be determined.There are a few external factors in post-manufacturing that could contribute to the issue: mechanical stress: over inflation due to to inappropriate syringe use, or, other factors: temperature extremes, poor placement technique, and/or long-term wear.Each of the above factors could lead to a balloon bursting and cannot be controlled outside of the manufacturing environment.Current spg (xeridiem) controls include training and certification of all production personnel and qc inspectors.Line clearances are preformed and documented at each workstation.All molds, presses and testing equipment used to manufacture the product line are documented within device history records and cleaned and calibrated when applicable.Controls surrounding the actual silicone material used include stringent storage, milling, cleaning, and extrusion rules.Detailed dhr/pic (pictorial instructions) are present at each workstation and deliver specific guidance for every step in the manufacturing process.Each balloon undergoes a 100% inflation test as part of the quality assurance process.The balloon is inflated and maintained in the inflated state for approximately 10 minutes.During this time, any defects such as leaks, structural weakness, or material inconsistencies are identified.Root cause: because the sample nor the lot were returned, the root cause could not be determined.Corrective and preventive 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.This investigation is complete at this time.No further information is available at this time.We will provide follow up information 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: 23487990
• Report Number: 2320762-2025-00017
• Device Sequence Number: 18763973
• Product Code: EYC
• UDI-Device Identifier: 00749756045773
• UDI-Public: 00749756045773
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 81-080414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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