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

Model Number 81-080416

Device Problem Suction Problem (2170)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device is being sent back for testing.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 Description

Post-op patients having multiple issues with significant hematuria, catheter obstruction and foley catheter displacement causing urinary retention.Upon review, there are concerns related to migration out of the bladder.

Manufacturer Narrative

Follow-up #2: the follow-up report #1 had a typo under the section b.2 "outcomes attributed to adverse event." the report mistakenly showed "death" as the outcome attributed to the adverse event.Neither the initial medical device report nor the device complaint resulted in an outcome related to death.Also, in section g.4 "premarket identification" it displayed the device as a "combination product", the device is not a combination product.

Manufacturer Narrative

A scar was completed by the supplier; however, no root cause was established due to device not being returned for supplier evaluation.Additional information was requested on the patient from deroyal for the supplier regarding the failure, the following information was provided: "i believe that the foley bulb had migrated into the urethra distal to the sphincter and was obstructing free flow of uring into the foley, unless the patient was bearing down to open up their ureteral sphincter." per the supplier (xeridiem), "given that the foley was able to drain with pressure gives the impression that there was no obstruction in the catheter causing the issue.This indicates an improper placement of the device at the facility in which it was used.Additional factors that may contribute to failure are related to patient specific factors such as diagnosis and treatment.Other possible factors that affect product performance include device handling, packaging, shipping, storage, cleaning, and maintenance." no manufacturing defect could be attributed to the failure, the supplier will continue to monitor for trends.Deroyal has sold 1,155 cases of finished goods of 81-080416 since (b)(6) 2019 to present with no similar complaints.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.

Manufacturer Narrative

Scar was completed however the actual device was not returned for evaluation; therefore, the defect could not be confirmed, and the root cause remains undetermined.The supplier's device history record of a seperate lot#1038301 was reviewed for line clearances, material verifications, qc inspections and sub-assembly manufacturing by the supplier's trained and certified staff.There was no scrap related to the drainage lumen and there were no non-conforming reports generated.On10/28/2020, there were 10,469 finished devices released to specification.However, two complaints were found for plugged drainage lumen in this lot.For previous year (june 2020-june 2021) three complaints for plugged drainage lumen were reported.Supplier corrective action: training with operators related to detection of splash in the drainage lumen was completed on 06/14/2021.Deroyal's engineering department performed testing on fourteen samples of the finished good #81-080416.Four samples were from the customer's remaining unused catheters (lot #54121772), and ten from deroyal's distribution center (lot#54821841).All samples passed static load test of inflated balloon response to traction.Thirteen out of fourteen passed impact load test and leak test.One catheter failed for filling it to 10cc (more than specified amount).This was most likely due to an error while handling the catheter prior to testing.Four samples of lot#54121772 and five samples of lot#548217841 passed flow rate test with results above the minimum requirement.Based on the testing performed, the products were not found to be defective.Deroyal has sold 1,549 cases in the last two years with one similar complaint related to plugged lumen.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
• Type of Device: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• MDR Report Key: 11855876
• MDR Text Key: 252385107
• Report Number: 2320762-2021-00003
• Device Sequence Number: 1
• Product Code: EYC
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-080416
• Device Lot Number: 52551381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR