MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER, 400 SERIES 8 FR; CATHETER, UPPER URINARY TRACT

Model Number	81-080408
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplier corrective action request (scar) was issued to the foley catheter supplier (xeridiem).Root cause: the device was not returned for evaluation.Besides the complaint description, no additional evidence was provided such as a sample, photos, or video; therefore, a physical or visual evaluation cannot be conducted.Without having more information, the defect could not be confirmed, and the root cause cannot be definitively determined by xeridiem.The lot number was not provided, therefore the investigation by xeridiem was limited to trending only.Trending was performed for the device family, defect codes, and the specific part number.It resulted in one other documented complaint.For the previous year complaints were reviewed for the device family and specific device in which there was only 1 reported complaint for balloon bursts/cuts/tears.Deroyal will not be taking any corrective action at this time, but will continue to monitor foley catheters for trends.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.
Additional Manufacturer Narrative
A user facility complaint was received on 08/23/2022 reporting, "burst foley balloon, led to dislodgement of indwelling urinary catheter.Large hole noted in balloon on inspection".A supplier corrective action request (scar) was issued to the foley catheter supplier xeridiem medical devices.The sample is not available for return to deroyal for evaluation.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation and corrective actions are determined.
Event or Problem Description
Burst foley balloon, led to dislodgement of indwelling urinary catheter.Large hole noted in balloon on inspection.
Additional Manufacturer Narrative
A user facility complaint was received on 08/23/2022 reporting, "burst foley balloon, led to dislodgement of indwelling urinary catheter.Large hole noted in balloon on inspection".A supplier corrective action request (scar) was issued to the foley catheter supplier (b)(4).The sample is not available for return to deroyal for evaluation.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information is concluded from the investigation and corrective actions are determined.
Event or Problem Description
Burst foley balloon, led to dislodgement of indwelling urinary catheter.Large hole noted in balloon on inspection.

• Brand Name: FOLEY CATHETER, 400 SERIES 8 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 newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19927886
• Report Number: 2320762-2022-00011
• Device Sequence Number: 2760550
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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
• Device Model Number: 81-080408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: Not provided; 08/23/2022
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024; 11/25/2024
• 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