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

Model Number 81-080416

Device Problems Suction Problem (2170); Material Perforation (2205); Infusion or Flow Problem (2964)

Patient Problems Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2021

Event Type  malfunction  

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 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
• Type of Device: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• MDR Report Key: 12514412
• MDR Text Key: 282295274
• Report Number: 2320762-2021-00008
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00749756045766
• UDI-Public: 00749756045766
• Combination Product (y/n): N
• PMA/PMN Number: K200757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-080416
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1