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

Model Number	81-080408
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "being used in a pt in the icu and the balloon burst.".
Additional Manufacturer Narrative
A user facility reported, "being used in a pt in the icu and the balloon burst." deroyal industries has requested return of the sample.A supplier corrective action request (scar) has been issued to the manufacturer of the foley, xeridiem medical devices.This 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 sample was provided to deroyal for evaluation.A supplier corrective action request (scar) has been issued to the manufacturer of the foley, xeridiem medical devices.This report came in as one complaint, but because it described four separate events, it will be reported for each event.This report is three of four (3/4).Deroyal industries evaluated the sample returned from the same lot of the affected device and no issues were found.Work orders for the affected lot and current inventory were reviewed with no issues identified.The failure mode effects analysis (fmea) and corrective actions and preventive actions were reviewed and no updates were required.A complaint to sales ratio was completed from (b)(6) 2022 to present and calculated to be 0.00035 or 0.0354%.The scar was completed by xeridiem medical devices.Returned samples were evaluated and inflated with air to specification and remained inflated.Root cause: sample evaluation and current processes were reviewed and no issues were found.Because of this, the complaint could not be confirmed and no root cause could be determined.Corrective and preventive actions: because no root cause was determined, no corrective or preventive actions were taken.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if information becomes available.
Additional Manufacturer Narrative
A user facility reported, "being used in a pt in the icu and the balloon burst." deroyal industries has requested return of the sample.A supplier corrective action request (scar) has been issued to the manufacturer of the foley, xeridiem medical devices.This 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.
Event or Problem Description
A user facility reported, "being used in a pt in the icu and the balloon burst.".

• 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: 19951305
• Report Number: 2320762-2023-00016
• Device Sequence Number: 8923808
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care 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
• Operator of Device: Health Professional
• Device Model Number: 81-080408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: Not provided; 11/10/2023
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024; 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