MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 14 FR (+/-0.1C); CATHETER, UPPER URINARY TRACT

Model Number	81-080414EU
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributing facility reported, "we only received notification of balloon bursting as there is no mention of actual procedure taking place." the distributed followed up and stated no injuries or outcomes were reported.
Additional Manufacturer Narrative
A distributing facility reported, "we only received notification of balloon bursting as there is no mention of actual procedure taking place." the distributed followed up and stated no injuries or outcomes were reported.Deroyal industries, inc.Has requested return of the device but it has not yet been received.A supplier corrective action request (scar) has been issued to the supplier, spectrum plastics.The investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Additional Manufacturer Narrative
A distributing facility reported, "we only received notification of balloon bursting as there is no mention of actual procedure taking place." the distributed followed up and stated no injuries or outcomes were reported.Deroyal industries, inc.Has requested return of the device and received it and sent to the supplier on 8/18/2026.Deroyal reviewed the work order for the product and no discrepancies were found.No finished goods from the lot were on hand for inspection.However, raw materials and 50 finished goods from a different lot were inspected.No defective products were identified.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 supplier, spectrum plastics.Spectrum inspected the returned sample and at first did not see an issue, however, during an inspection test when hands were removed from the shaft, a small hole was observed.The device history record (dhr) was reviewed for this lot.No discrepancies were found and all specifications were noted to be met.Spectrum noted that it was possible that this hole could have occurred by being nicked with a sharp or abrasive edge during the manufacturing process or due to handling or guiding components during use.Spectrum does 100% inflation and visual inspections for damage.100% of units are inflated with 12 cc of air and left for 10 minutes to identify any leaks or defects.Root cause: while the defect was confirmed, the specific cause of the hole was unable to be determined.It is possible that it could have occurred during manufacturing or during use.Corrective and preventive actions: spectrum trained operators on this defect to ensure awareness.Deroyal will continue to monitor for trends around this item and issue.The 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 (+/-0.1C)
• 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: 22629807
• Report Number: 2320762-2025-00011
• Device Sequence Number: 9002946
• Product Code: EYC
• UDI-Device Identifier: 00749756596657
• UDI-Public: 00749756596657
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/03/2026

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: 81-080414EU
• Device Lot Number: 61490947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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