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

Model Number	81-080416
Medical Device Problem Codes	Suction Problem (2170); Material Perforation (2205); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause was undetermined.Per customer the defective device was discarded and lot number is unknown; therefore, we were not able to complete a thorough investigation.Unable to look into work order or send a supplier corrective action request (scar) without this information.The customer has reported issues as this event in the past and deroyal's engineering team has done testing and no issues were found on previous reported events.During the period of august 2019 - present, deroyal has (b)(4).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.
Event or Problem Description
The patient came to the recovery room with a foley catheter draining clear amber urine.When the blankets were being straightened by a health professional, catheter tubing was left on the bed.When the catheter tubing was being straightened, the foley bulb fell out of the urethra.The bulb was not inflated and the nurse proceeded to try to inflate.The bulb inflated, however, the next minute it did not stay inflated.

• 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: 12514412
• Report Number: 2320762-2021-00008
• Device Sequence Number: 3913452
• Product Code: EZL
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1