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 Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The catheters clogged every time where the patient gets a proper bladder retention with all its consequences.It seems that this is related to the balloon change.
Additional Manufacturer Narrative
Reporter submitted the following: "the catheters clogged every time where the patient gets a proper bladder retention with all its consequences.It seems that this is related to the balloon change." this report came in as one complaint, but because it described nine separate events, it will be reported for each event.This report is six of nine (6/9).A supplier corrective action request (scar) was issued to the foley catheter supplier xeridiem medical devices.In reference to "balloon change", there has been no design change to what is currently in the field.Investigation is underway to determine the nature of this comment as well as the root cause of the issue.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.
Additional Manufacturer Narrative
The sample was discarded so no samples were available for return to deroyal industries.A supplier corrective action request (scar) was issued to the foley catheter supplier xeridiem medical devices.This report came in as one complaint, but because it described nine separate events, it will be reported for each event.This report is six of nine (6/9).It was determined that these complaints took place over the span of 12 months.With that, in reference to the "balloon change," there has been no change to the catheters provided by xeridiem.Xeridiem does not consider this issue to be an out of box failure.The device was functional prior to patient application and observed as latent failures from use.Device history records were reviewed and found to be within specification.Xeridiem also reviewed risk documentation and any open corrective action and preventive action (capa) points, no capas or new risk information was identified.A compliant record review was completed by xeridiem, between may 2022 and june 2023, over (b)(4) units were sold and there were (b)(4) device defects for plugged lumen.Root cause: was unable to be confirmed by the supplier xeridiem medical devices.Potential root cause: because these complaints were not considered to be out of box failures, there are other factors or possibilities that may have induced device malfunctions.These factors can include diagnosis and treatment, device handling, environment, storage, cleaning, maintenance, patient conditions, and other elements that are out of xeridiem's control.Each of these conditions could potentially induce device malfunctions; however, these devices are not permanent and shall be cared for and replaced as needed or required.Corrective and preventive actions: because xeridiem could not confirm the issue, no corrective or preventive actions will be taken.Deroyal industries also conducted an investigation.Specifications, work orders, and inventory checks were conducted and no issues were found.Labeling, capas, and failure modes and effects analysis (fmea)'s were also reviewed, with no issues or missing information found.Deroyal also created a complaint to sales ratio: between may 2022 and june 2023, deroyal has sold (b)(4) units ((b)(4) individual foleys) of item 81-080416eu.During that same time frame, a total of 9 complaints were received for this product.This equates to a complaint ratio of (b)(4).Deroyal will continue to monitor for trends around this item and issues.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if more information will become available.
Event or Problem Description
The catheters clogged every time where the patient gets a proper bladder retention with all its consequences.It seems that this is related to the balloon change.
Additional Manufacturer Narrative
Reporter submitted the following: "the catheters clogged every time where the patient gets a proper bladder retention with all its consequences.It seems that this is related to the balloon change." this report came in as one complaint, but because it described nine separate events, it will be reported for each event.This report is six of nine (6/9).A supplier corrective action request (scar) was issued to the foley catheter supplier xeridiem medical devices.In reference to "balloon change", there has been no design change to what is currently in the field.Investigation is underway to determine the nature of this comment as well as the root cause of the issue.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.

• 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 newman ; 200 debusk lane; powell, TN
• MDR Report Key: 19932604
• Report Number: 2320762-2023-00009
• Device Sequence Number: 16834385
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200757
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 81-080416EU
• Device Lot Number: 57172153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: Not provided; 05/05/2023
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/08/2024; 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown