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

Model Number 8888145044C

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter.The customer of the palindrome h 23 cm on (b)(6) 2016 without complications.The catheter was sutured.Before connecting to dialysis on this day, the nurse discovered a leakage, and discovered a hole on one of the silicone extenders situated midway on the extension line.The patient had to go through a change of the catheter with no other complications.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this condition were found.There are no non conformance reports (ncr)¿s related to the reported issue and lot.The product sample was returned for investigation; it consisted of one part of the extension tube with a length of 3 cm approximately.A visual inspection was performed and no imperfections were found on the tubing.Functional testing was conducted and the product extension did not present any imperfections.Based on the complaint description the condition was not identified prior the insertion and the device functioned as intended for the first hours.Additionally, manufacturing performs a 100% visual inspection on catheter extensions and a 100% high pressure (leak) test.The product specification was reviewed in order to identify the possible root causes for the leaking.The most probable root cause could occur during use caused due to the use of sharp objects, repeated clamping or other similar damage as described in the instructions for use.Should the sample be returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.Manufacturing performs a 100% leak test and a 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME EMERALD 23/40 KIT
• 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 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5357173
• MDR Text Key: 35971223
• Report Number: 3009211636-2016-00031
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145044C
• Device Catalogue Number: 8888145044C
• Device Lot Number: 322716X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR