MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNKNOWN DIALYSIS

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer reports that the catheter became damaged on (b)(6) 2015.Presence of air was observed in the tubing of the arterial side circuit.Treatment was put on hold to verify the cvc.A crack was observed under the rigid white y(bifurcate).Cvc was clamped with a small white clip above breakage.Doctor was advised.Date of implantation: (b)(6) 2012, removal date: (b)(6) 2015.Nothing went wrong before date of incident.Used another device without further consequence.The patient underwent an installation of central venous catheter tunneled right internal jugular vein on (b)(6) 2015.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample and photo was received for evaluation.The product sample consisted of one palindrome catheter.A visual inspection was performed and a hole was found on the joint of the catheter, below the hub.Functional testing (underwater test) was performed and bubbles were detected coming out below the hub, from the lumen which corresponds to the arterial extension.The lumen corresponding to the venous extension did not show bubbles during the test.The device was in use for 2 years and 8 months.There device was more likely damaged during use.The most probable root cause can be due to inappropriate use of cleaning agents or excessive force used.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes or cuts which could impair its performance.This event will be handled through a formal corrective and preventative action and no additional actions are required.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4691122
• MDR Text Key: 5636103
• Report Number: 3009211636-2015-00200
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN DIALYSIS
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR