MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, UPPER URINARY TRACT

Model Number BS81-080414

Device Problems Complete Blockage (1094); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Urinary Retention (2119)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (b)(4) was received reporting that a foley catheter (part bs81-080414, lot 48279557) had a blockage in the inner lumen, which resulted in no urine drainage.This caused a urinary catheterization failure on the operating patient.It was reported that the patient was not injured.Initially, the defective sample was reported to be available for return.However, no sample was returned.Photos of the defective sample were provided instead.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A blockage was found in the inner lumen of a foley catheter, which resulted in no urine drainage.This caused urine catherization failure on an operating patient.The patient was not injured.The catheter balloon tested ok.

Manufacturer Narrative

Root cause: the catheter portion of the device is contract manufactured by degania silicone.Therefore, a supplier corrective action request (scar) was issued to degania.In its response, the manufacturer stated that silicone material can sometimes flow into the main lumen during the funnel injection process, causing complete or partial blockage.Corrective action: in its scar response, degania stated it has informed all applicable personnel related to this issue and a quality alert indicator has been published on the all at the injection molding machine to increase awareness.Investigation summary an internal complaint (call 46404) was received reporting that a foley catheter (part bs81-080414, lot 48279557) had a blockage in the inner lumen, which resulted in no urine drainage.This caused a urinary catheterization failure on the operating patient.It was reported that the patient was not injured.Initially, the defective sample was reported to be available for return.However, no sample was returned.Photos of the defective sample were provided instead.The silicone catheter portion of the device is contract manufactured by degania silicone.Therefore, a scar was issued to degania.A response was received and accepted april 15 by deroyal's complaint investigator.A review of sales and similar complaint information showed the following: 1) deroyal has sold 502 cases of the affected finished good from february 2017 to present and 2) during the same review period, only one complaint was received for this product.This equates to a complaint-to-sales ratio of 0.001.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A blockage was found in the inner lumen of a foley catheter, which resulted in no urine drainage.This caused urine catherization failure on an operating patient.The patient was not injured.The catheter balloon tested ok.

• Brand Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Type of Device: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 8439529
• MDR Text Key: 139573515
• Report Number: 2320762-2019-00001
• Device Sequence Number: 1
• Product Code: EYC
• Combination Product (y/n): N
• PMA/PMN Number: K041416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BS81-080414
• Device Lot Number: 48279557
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1