MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L FOLEY CATHETER

Model Number 81-080416

Device Problems Display or Visual Feedback Problem (1184); Suction Problem (2170); 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 05/27/2021

Event Type  malfunction  

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 issues; however, still waiting for completion.

Event Description

During day three of post-operation, the patient was showing signs of low urine output, she was started on a diuretic infusion to facilitate fluid removal and diuresis.The foley catheter was bypassing urine onto the bed, so the nurse assessed the system.This included a bladder scan which showed a retained volume of >999ml in her bladder despite having a catheter insitu.The nurse attempted to irrigate the foley for obstruction and was unsuccessful.In fact the irrigation fluid bypassed around the catheter an onto the bed as well.The balloon of the foley was deflated in preparation for removal and the patient was incontinent of large volumes of urine.Following this, a new catheter was placed and drained 1.5 l of urine, and >1 l in the hour following.The patient was sedated during this event so was unable to communicate discomfort or urge to void.This patient was unnecessarily exposed to high dose diuretics and high-volume urine retention which could have caused significantly renal dysfunction.

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 (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 #(b)(4).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
• Type of Device: CATHETER
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 11983416
• MDR Text Key: 255710047
• Report Number: 2320762-2021-00004
• 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
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• 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: 54121772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR