MAUDE Adverse Event Report: COSTA RICA PALINDROME EMERALD 19/36 SPORT W/ VT; DIALYSIS CATHETER

Model Number 8888119365

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

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 states that catheter was cracked below the hub.Patient: male, (b)(6); hd patient.No patient injury or ill-effects.Catheter was removed and replaced.The device will be returned for evaluation.

Manufacturer Narrative

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 returned consisted of one 14.5 fr palindrome catheter, 19 cm implant length, 36 cm with signs of use.After a visual inspection was performed, a hole was found on the joint of the catheter below the hub.During functional testing (underwater test), bubbles were detected coming out below the hub, from the lumen which corresponds to the arterial extension.The lumen related to the venous extension did not show bubbles during the test.As per the instructions for use, the customer has 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.The catheter functioned as intended for 2 years and 4 months.The issue was noticed during use.The most probable root cause could be due to damage during the medical procedure.The leak can be due to excessive force or inappropriate use of cleaning agents.The lot involved on this event was manufactured on (b)(6) 2012, before the implementation date of actions related to a corrective and preventative action.It was defined that this event is being handled through this capa 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 nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME EMERALD 19/36 SPORT W/ VT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COSTA RICA; 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: 4341244
• MDR Text Key: 20362415
• Report Number: 3009211636-2014-00201
• Device Sequence Number: 1
• Product Code: NYU
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 8888119365
• Device Catalogue Number: 8888119365
• Device Lot Number: 200620X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2012
• 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
• Patient Age: 56 YR