MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL FOLEY CATHETER, 400 SERIES 10 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080410
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "the end of each foley keeps coming apart." deroyal industries, inc.Requested return of the device, but it has not yet been received.A supplier corrective action request (scar) will be issued to the supplier, spectrum plastics.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 end of each foley keeps coming apart.".
Additional Manufacturer Narrative
A user facility reported, "the end of each foley keeps coming apart." deroyal industries, inc.Requested return of the device, and received it on 8/19/2025.A supplier corrective action request (scar) was issued to the supplier, spectrum plastics.The sample was also sent to spectrum plastics for their inspection.Spectrum reviewed and inspected the sample and stated that it appears that the sensor molded connector was not properly over-molded to the tubing and fell off with minimal force.The sensor wire that sits inside the sensor lumen was not kinked which indicated there was no excessive pull force exerted on the overall sensor.Deroyal inspected one case of foley's on hand at distribution and no issues could be identified through visual inspection.Because no lot number was provided, the specific device history record (dhr) could not be reviewed, however, deroyal did review photos provided in the scar from the supplier and noted that it appears that the sleeve was not properly positioned at the time the connector was molded.If this situation occurs, there is a risk that the sleeve may become disconnected from the connector.A complaint to sales ratio was conducted over the past two years and found to be 0.06%.Root cause: the issue occurred because the sleeve was not properly positioned during the connector molding process.This improper positioning allowed the sleeve to be displaced, creating a weak bond between the sleeve and the connector.As a result, there is a risk that the sleeve may become detached from the connector.Corrective and preventive action: the supplier did not take any corrective or preventive actions, however, deroyal did conduct additional training to ensure all molding operators were aware of this issue and how to detect the improper positioning.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: DEROYAL FOLEY CATHETER, 400 SERIES 10 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: 22749637
• Report Number: 2320762-2025-00013
• Device Sequence Number: 18321845
• Product Code: EYC
• UDI-Device Identifier: 00749756045797
• UDI-Public: 00749756045797
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/14/2025

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: 81-080410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 11/14/2025
• 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