MAUDE Adverse Event Report: COVIDIEN PALINDROME RUBY 28/45 KIT VT; DIALYSIS CATHETER

Model Number 8888145064

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/02/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with a dialysis catheter.The customer states that there are small bubbles at the distal end of the si sleeve.The catheter was explanted from the patient and replaced.

Manufacturer Narrative

As no lot number was identified, a manufacturing device history review or product/process change review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was returned for analysis and investigation; it consisted of one palindrome his catheter.The catheter came inside a generic plastic bag and showed signs of use (remains of blood and wear on the cuff).Visual inspection was performed; it was observed that the catheter was cut approximately 4.5 inches below the cuff and it was observed that a section of the am sleeve had bubbles.Maximized photos were taken to capture the issue.The bubbles were cut and it was noted that air was between the upper and lower layer; a longitudinal cut was performed to the am sleeve and it was observed that the catheter area and lower layer were clean and no visible issues were observed.According to the instructions for use (ifu) it is necessary to perform a visual inspection before using the device.Do not use the catheter or components if they appear damaged or defective.Do not use acetone on any part of the catheter.While other solutions are listed in the ifu which can be used, inter-mixing of these solutions has not been tested and is not recommended.Potential complications include: subcutaneous tunnel infection, hypersensitivity reactions; local irritation; and skin necrosis.Heparin coated catheters should not be used in individuals with documented hypersensitivity to heparin or porcine based products.Heparin coated catheters should not be used in patients with severe thrombocytopenia, uncontrollable active bleeding disorders, or with skin necrosis from previous heparin use.Catheters containing silver should not be used in patients with known hypersensitivity to silver.It is unknown if there was use of another agent additional to the alcohol to clean the catheter and which percent of alcohol was used (only isopropyl alcohol 70%, can be used), and if the patient condition affected the use of the silver am sleeve use, however the catheter was in good condition at the moment of the initial insertion and during an undetermined period.The most possible cause for this issue is the use of an improper cleaning agent or a patient condition (hypersensitivity to silver).The heparin and the silver impregnated sleeve guarantee the reduction of platelet adhesion and colonization for 24 and 30 days respectively.The am sleeve is tested according to material specifications.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.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 nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME RUBY 28/45 KIT VT
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6142920
• MDR Text Key: 61699474
• Report Number: 3009211636-2016-00496
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888145064
• Device Catalogue Number: 8888145064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1