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

Model Number 8888541019

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2015

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 09/23/2015 that a customer had an issue with a dialysis catheter.The customer report during dialysis the device stopped 3 times because of presence of air inside the lines.They noticed a failure on the screw thread of the catheter branch tunneled central venous.This extended time of the dialysis because the device was changed and only 0.7l of blood has been treated instead of 1.5l.They noticed a blood leak at the venous connector site.The patient was grafted in emergency on the (b)(6) 2015 following a vascular issue.Because of no return of the kidney functional activity, a daily dialysis was needed.The device was placed in the right femoral on the (b)(6) 2014.The dialysis was interrupted to change the connector on a precarious vascular access.The adapter was changed and the catheter was pulled and replaced.There was no medical intervention.

Manufacturer Narrative

Submit date: 1/11/2016.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.This event will be handled through a formal corrective and preventative action 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, in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% 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 RT 15FR 19CM 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 ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5117145
• MDR Text Key: 27481265
• Report Number: 3009211636-2015-00378
• 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,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR