MAUDE Adverse Event Report: COVIDIEN PALINDROME 28/45 KIT W/ SLOT; DIALYSIS CATHETER

Model Number 8888145016

Device Problem Hole In Material (1293)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/22/2016.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.The customer states the palindrome chronic catheter was placed on (b)(6) 2016 in the patient where there was no leak at the time of placement.The patient dialyzed successfully after placement that same day.On (b)(6) 2016, the dialysis outpatient unit was noticed bleeding upon the patients arrival to the unit.The patient asked to visit the er at (b)(6) hospital where the patient was then taken to the ir department.The doctor exchanged the palindrome chronic catheter and noticed small pin holes in the catheter extension (red arterial side).

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this condition were found.There are no non conformance reports (ncr)¿s related to the reported issue and lot.The product sample was returned for investigation; a palindrome catheter, clip and syringe were received inside a generic plastic that presented signs of use (remains of blood).A visual inspection was performed and pinholes were found on the arterial extension.In order to confirm the condition reported functional test was required.The returned sample was submitted to underwater testing and bubbles were detected coming from pinholes of the extension of catheter, from the lumen which corresponds to the arterial extension.The lumen related to the venous extension did not show bubbles during the test.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 device functioned as intended for the reported amount of time.Additionally, manufacturing performs a 100% visual inspection on catheter extensions and a 100% high pressure (leak) test.The product specification was reviewed in order to identify the possible root causes for the leaking.The most probable root cause could occur during use caused due to the use of sharp objects, repeated clamping or other similar damage as described in the instructions for use.Should the sample be returned in the future, this complaint will be re-opened for further investigation.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 nonconforming product from leaving the manufacturing operations.Manufacturing performs a 100% leak test and a 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME 28/45 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 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: 5385399
• MDR Text Key: 36765622
• Report Number: 3009211636-2016-00049
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

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: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 1429700221
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 01/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 99