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

Model Number	81-080416
Medical Device Problem Codes	Suction Problem (2170); Compatibility Problem (2960); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Abdominal Pain (1685); 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
The patient returned from the operation room with zero urine in the foley catheter bag and the urometer was dry and collapsed without signs of any collection inside.The operation room report showed ultrafiltration of 2 l fluid removal.The nurse receiving the case did troubleshooting of the catheter and irrigated with no return, also a bladder scan displayed for 350 ml.Balloon deflated and catheter cleaned and advanced further into bladder, balloon re-inflated.Urine output continued to be low over the next 12 hours, however was clear with no clots and no further management until patient complained of severe abdominal pain the morning after surgery.Bladder scanned again displayed to be retaining urine.Foley again irrigated but unable to flush or withdraw irrigation fluid, following with foley catheter removed.Patient incontinent of urine.Foley catheter remained out and patient able to void without issue.
Additional Manufacturer Narrative
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: FOLEY CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• MDR Report Key: 12106759
• Report Number: 2320762-2021-00007
• Device Sequence Number: 11912453
• 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: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• 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