MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER

Model Number	81-080416
Medical Device Problem Codes	Decrease in Suction (1146); Suction Problem (2170)
Health Effect - Clinical Codes	Unspecified Kidney or Urinary Problem (4503); Urinary Incontinence (4572)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation therefore we were not able to complete a thorough investigation.A supplier corrective action request (scar) has been sent to vendor (xeridiem medical devices) in relation to the product issue; however, still waiting for completion.The investigation is incomplete at this time, a follow-up report will be submitted with additional information once received, this report will be updated.
Event or Problem Description
Patient was started on a lasix infusion due to low urine output over a few hours.In the following hours her foley catheter was bypassing large amounts of urine, the nurse investigated the system including a bladder scan.The bladder scan was found to have >999 ml.As per unit protocol, the catheter was irrigated to relieve any obstruction but non were found.The catheter balloon was deflated in preparation for removal and the patient was releasing large volume of urine into the bed.Following which, a new foley was inserted and an additional 1.5l of urine was collected.An additional >1l was collected in the following hour as well.The patient was sedated and intubated post operatively, hence unable to communicate discomfort associated with significant urinary retention.
Additional Manufacturer Narrative
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
• Common Device Name: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• MDR Report Key: 12106752
• Report Number: 2320762-2021-00006
• Device Sequence Number: 17293460
• Product Code: EYC
• UDI-Device Identifier: 00749756045766
• UDI-Public: 00749756045766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 81-080416
• Device Lot Number: 54121772
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1