MAUDE Adverse Event Report: COSTA RICA PALINDROME RT 15FR 19CM KIT; DIALYSIS CATHETER

Model Number 8888541019

Device Problem Air Leak (1008)

Patient Problem Blood Loss (2597)

Event Date 08/15/2014

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 the user noticed microbubbles in the circuit during connection.The catheter was applied on (b)(6) 2014.Another catheter was used.The patient lost blood.Hemoglobin value on (b)(6) 2014: 12,9g/dl.

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.No changes in the process were identified to be related with this event.The product sample returned consisted of one 15 fr tal palindrome rt catheter, 19 cm implant length, and 39 cm overall length.The catheter was cut approximately 3 cm below the hub and it came inside a generic plastic bag.Visual inspection was performed and a crack was found on the red adult adapter, in the thread area.The blue adult adapter did not present any issues.Based on 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.Over tightening the catheter connection can crack some adapters.The issue experienced was not noted prior to use.The adapter was more likely damaged during use.The most probable root cause is likely due to over tightening as excessive force could have been the cause of the damage.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.As per procedure, manufacturing performs 100% visual inspection during production, which would identify cracked adapters in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME RT 15FR 19CM KIT
• 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: 4220947
• MDR Text Key: 5066677
• Report Number: 3009211636-2014-00139
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/10/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888541019
• Device Catalogue Number: 8888541019
• Device Lot Number: 306619X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2015
• 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
• Patient Age: 57 YR