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

Model Number	81-080416
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); 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	05/31/2021
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 (b)(4) in relation to the product issues; 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
During day zero of post-operation, the patient was showing with no urine output in operating room.When assessed by the nurse by a bladder scanner he had 350 ml in his bladder despite having a foley catheter insitu.This was irrigated and urine clear of clots came out.Low volumes of urine continued to drain in the following 12 hours, however the patient was experiencing increasing abdominal pain and urge to void.When assessed the catheter was unable to irrigate, and the bladder scan showed residual urine in the bladder.The foley catheter was removed and the patient was incontinent of large amounts of urine.This patient experiences significant and painful urinary retention despite the catheter being insitu.
Additional 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 of all line clearances, material verifications and qc inspections and for 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.On 10/28/2020, there were (b)(4) finished devices released to specification.However, two complaints were found for plugged drainage lumen in this lot.For previous year ((b)(6) 2020- (b)(6) 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 (b)(6) 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 for static load test of inflated balloon response to traction.Thirteen out of fourteen passed for impact load test and leak test.One catheter failed by filling 10cc more than specified amount most likely due to an error while handling the catheter prior to testing.Four of samples lot #54121772 catheter and five of samples lot #548217841 passed flow rate test above the minimum requirement.Based on the testing performed, the products were not found to be defective.Deroyal has sold (b)(4) cases in the last two years with one similar complaint of 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
• Common Device Name: CATHETER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• MDR Report Key: 11998430
• Report Number: 2320762-2021-00005
• Device Sequence Number: 1100255
• Product Code: EYC
• UDI-Device Identifier: 00749756045766
• UDI-Public: 00749756045766
• Combination Product (Y/N): Y
• 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
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR