MAUDE Adverse Event Report: COVIDIEN PALINDROME 23/40 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145015

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer reports there is a break in bifurcate.The catheter was placed on (b)(6) 2014, it leaked on (b)(6) 2014 and replaced on (b)(6) 2014.The catheter was in placed for 7 months.There was no injury to the or impact to the patient's health.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue.The product sample was received in a generic plastic bag.It consisted of one assembled catheter 14.5fr palindrome with slots.After visual inspection, issues were identified during functional testing (underwater test) bubbles were detected coming out below the hub from the lumen which corresponds to the venous extension.The lumen corresponding to the arterial extension did not show bubbles during the test.As per the instructions for use, it is necessary to perform a visual inspection before using the device, stating do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.It is important to inspect the catheter frequently for nicks scrapes, and cuts which could impair its performance.The customer indicated that the catheter functioned as intended for 7 months; therefore the device was more likely damaged during that time.Based on the available information, the probable root cause can be that a leak was more likely caused due to the inappropriate use of cleaning agents.The lot involved in this complaint was manufactured on 07/26/11, before the initiation of a corrective and preventive action (capa) dated 01/09/15.

Event Description

Following evaluation, it was defined that this event is being handled through this capa and will be used to track the delayed adoption of revised cleaning protocols in the (b)(6) market for these products.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100 percent in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100 percent leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME 23/40 KIT W/ SLOT
• 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: 4367923
• MDR Text Key: 16089657
• Report Number: 3009211636-2014-00210
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 119494
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1