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

Model Number 8888145015

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Obstruction/Occlusion (2422); Cancer (3262)

Event Date 02/17/2016

Event Type  Death  

Manufacturer Narrative

Submit date: 3/31/2016 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 and had subsequently passed.The customer stated that there is no flow in the arterial limb of the palindrome 23 but good flow on reversal.The patient involved in this report has expired.The date of the catheterization (surgery) for this patient was on (b)(6) 2013.The doctor did confirm that the reason for the death was not catheter related.The patient died because of advanced colon cancer with infiltration to both ureters causing obstructive uropathy.

Manufacturer Narrative

Submit date: 07/25/2016.The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no nonconformance reports related to the reported issue for the involved lot.No changes were identified that may impact the product or process related to the reported condition during a period of six months prior to the manufacturing date.The actual sample involved in the reported incident was not returned to the plant for evaluations.The sample was received from the customer at the decon lab in mansfield; however, it was inadvertently lost prior to shipment to the plant.A photo (x-ray) was attached to the complaint record that shows the catheter was introduced into the patient.Additionally, we received 3 videos that show prior to line reversal, after line reversal, and aspiration.The videos and the photo did not reveal any problem with the catheter; the lines were in the correct position and did not shows kinks or another issue that could have caused the occlusion reported.An ishikawa diagram was used and the possible root causes were identified.Manufacturing performs 100% testing of the catheters in order to determine if any material obstructs the tubing or if the slots are blocked.The complaint was not confirmed.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that the product was manufactured according to specifications and the most probable root cause can be considered as a patient related condition or catheter placement.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% visual inspection, and visual acceptance sampling are performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.No additional actions are required.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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5538696
• MDR Text Key: 41573571
• Report Number: 3009211636-2016-00146
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 222926X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• 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 Outcome(s): Other