MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 16 FR (+/-0.1C); CATHETER, UPPER URINARY TRACT

Model Number	81-080416EU
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Deflation (4061)
Health Effect - Clinical Code	Tissue Irritation (4912)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A user facility reported, "the need to replace three bladder catheters with thermistor ch16 ref 81-080416eu is reported due to repeated deflation of the balloon and consequent displacement of the catheter.In all cases, the catheter was found out of place with the balloon deflated.It should be noted that the problem occurred with only one patient and that him was later discovered with a urethral stone, thus raising the question of a correlation with the event that occurred." deroyal industries, inc.Requested return of the device, but the device was unable to be returned as it had been discarded.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.
Event or Problem Description
A user facility reported, "the need to replace three bladder catheters with thermistor ch16 ref 81-080416eu is reported due to repeated deflation of the balloon and consequent displacement of the catheter.In all cases, the catheter was found out of place with the balloon deflated.It should be noted that the problem occurred with only one patient and that him was later discovered with a urethral stone, thus raising the question of a correlation with the event that occurred.".
Additional Manufacturer Narrative
A user facility reported, "the need to replace three bladder catheters with thermistor ch16 ref 81-080416eu is reported due to repeated deflation of the balloon and consequent displacement of the catheter.In all cases, the catheter was found out of place with the balloon deflated.It should be noted that the problem occurred with only one patient and that him was later discovered with a urethral stone, thus raising the question of a correlation with the event that occurred." deroyal industries, inc.Requested return of the device, but the device was unable to be returned as it had been discarded.Deroyal reviewed the work order and no discrepancies were found.Inventory of 2831 raw materials was inspected and no issues were found by visual inspection.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 (xeridiem).Because no sample was returned, spectrum could not inspect the sample for specific issues.The device history record for the lot of the returned product was inspected and no issues were found as all products were found to be within specifications.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 period, any defects such as leaks, structural weakness, or material inconsistencies are identified.There are potential external factors that could contribute to a balloon tear such as mechanical stress from overinflation due to inappropriate syringe use or other factors such as temperature extremes and poor placement techniques.Root cause: because the sample was not returned and no issues could be found within the manufacturing records, the exact 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.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.
Additional Manufacturer Narrative
A user facility reported, "the need to replace three bladder catheters with thermistor ch16 ref 81-080416eu is reported due to repeated deflation of the balloon and consequent displacement of the catheter.In all cases, the catheter was found out of place with the balloon deflated.It should be noted that the problem occurred with only one patient and that him was later discovered with a urethral stone, thus raising the question of a correlation with the event that occurred." deroyal industries, inc.Requested return of the device, but the device was unable to be returned as it had been discarded.Deroyal reviewed the work order and no discrepancies were found.Inventory of 2831 raw materials was inspected and no issues were found by visual inspection.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 contract manufacturer, spectrum plastics (xeridiem).Because no sample was returned, spectrum could not inspect the sample for specific issues.The device history record for the lot of the returned product was inspected and no issues were found as all products were found to be within specifications.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 period, any defects such as leaks, structural weakness, or material inconsistencies are identified.There are potential external factors that could contribute to a balloon tear such as mechanical stress from overinflation due to inappropriate syringe use or other factors such as temperature extremes and poor placement techniques.Root cause: because the sample was not returned and no issues could be found within the manufacturing records, the exact 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.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 16 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: 23817646
• Report Number: 2320762-2025-00021
• Device Sequence Number: 9409770
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81-080416EU
• Device Lot Number: 61524385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/18/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown