MAUDE Adverse Event Report: COVIDIEN PALINDROME H 19/36 KT VT X5; DIALYSIS CATHETER

Model Number 8888145043C

Device Problems Air Leak (1008); Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 2015.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer states that one of the extensions cracked next to the clamps and was leaking blood and air.The catheter was placed on the (b)(6) 2015.Dialysis was stopped and the catheter was replaced.The patient condition is good.

Manufacturer Narrative

This complaint was investigated.The device history record was reviewed and indicated that the product was release accomplishing all quality standards.A sample was not received to the site for investigation.However, two photos were provided by the customer and blood inside the venous extension was observed.It was also noted rests of blood on the clamp of the blue extension; however the evidence provided is not enough for determine any defect on the catheter.The catheter functioned as intended for 20 days.As per the instructions for use (ifu), it is necessary to perform a visual inspection before using the device.Do not use the catheter if it is crushed, cracked, cut or otherwise damaged.Clamping the catheter repeatedly in the same spot could weaken the tubing.Exercise caution when using sharp instruments near the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, cuts, etc., which could impair its performance.The defect was not identified prior the insertion and the device functioned as intended for the above-mentioned amount of time.Additionally, manufacturing performs 100% visual inspection on catheter extensions and 100% high pressure (leak) test.Also, this defect was reproduced by puncturing a new silicone extension with a scalpel.Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time.Moreover, 100% devices are inspected for leaks or cuts in the extensions.Therefore the most probable root cause could be due to therefore misuse such as improper use of sharp objects, repeated clamping or other similar damage.Actual occurrence percentage for this failure mode was found higher than expected.A qseas evaluation took place to assess this exceeded risk threshold, no further investigation activities or corrective actions were required and an hhe evaluation was opened to address this failure mode in this product family.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection, leak testing and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing and a 100% visual inspection at the final stage of production, which would identify this issue in the catheter assembly.No additional actions are required.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure were found.There are no non-conformances related to the reported issue for the involved lot.There were no changes identified that may impact the product/process related to the reported condition during a period of six months prior to the manufacturing date.Two photos were provided by the customer and the photos observed the venous extension with blood inside them.It can be noted that there was remains of blood on the clamp of the blue extension; however the evidence provided is not enough to determine any defect on the catheter.A sealed sample from product id 8888145043c was received for analysis and investigation.There were no visible defects found during visual inspection.The functional testing was required in order to confirm the issue reported by the customer and after the test the catheter did not show any leak in the tubing of the extensions.As per the instructions for use (ifu); it is necessary to perform a visual inspection before using the device.Do not use the catheter if it is crushed, cracked, cut or otherwise damaged.Clamping the catheter repeatedly in the same spot could weaken the tubing.Exercise caution when using sharp instruments near the catheter.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes, and cuts which could impair its performance.The dwell time was 20 days and the issue was not identified prior to the insertion and the device functioned as intended for a period of time.Additionally, manufacturing performs 100% visual inspection on catheter extensions and 100% high pressure (leak) testing.As part of the investigation, this defect was reproduced by puncturing a new silicone extension with a scalpel.This defect could be related to the use of sharp objects.According to the photos and unused sample provided by the customer, the defect was not confirmed with the visual and functional testing.

Event Description

Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time.In addition, 100% of the devices are inspected for leaks or cuts in the extensions per procedure.The most probable root cause is that the tubing was more likely damaged during use, coming in contact with a sharp object or repeated clamping or other similar damage.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection, leak testing and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% leak testing and a 100% visual inspection at the final stage of production, which would identify this issue in the catheter assembly.No additional actions are required.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME H 19/36 KT VT X5
• 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: 5196182
• MDR Text Key: 30499674
• Report Number: 3009211636-2015-00440
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145043C
• Device Catalogue Number: 8888145043C
• Device Lot Number: 1504700103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1