MAUDE Adverse Event Report: COVIDIEN 36CM PERM CATH KIT X5; DIALYSIS CATHETER

Model Number 8817748001

Device Problem Air Leak (1008)

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

Event Date 11/01/2015

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 (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that the catheter was found that it has a slow bleed and air bubbles the second day after the first implantation.The catheter was pulled and replaced right away.The patient was involved with no injury.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A physical sample was not received for evaluation; however, two pictures were received for a visual inspection.One photo showed part of the hub and the other photo showed the catheter inside a patient with a drop of blood just below the hub.As per 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.Catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes, or cuts which could impair its performance.Do not use acetone on any part of the catheter.A possible root cause can be due to excessive force used with the device.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 non-conforming product from leaving the manufacturing operations.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 mode were found.There are no non-conformances related to the reported issue for the involved lot.The product sample and two pictures were provided by the customer and visual evaluation of the photos was performed.In one of them it could be observed that there was a portion of the hub and catheter with a hole between these 2 sections.In the other picture it was observed that the catheter was inside the patient body with a drop of blood below the hub.Additionally the samples were received inside a generic plastic bag and it presented sings of use (it was cut and there was blood residue).The sample was submitted to an underwater test and bubbles were detected, they were coming out below the hub.A hole was noted just below the hub.According to the event description the leak was identified two days after implantation which implies that the defect was not present at the moment of the insertion and it occurred after manipulation.As per 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.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, or cuts which could impair its performance.Do not use acetone, alcohol, or any solution containing alcohol on any part of the catheter.Exposure to these agents may cause catheter damage.Aqueous-based povidone is recommended.Based on the available information and dhr review, it can be concluded that the product was manufactured according to specifications and functioned as intended for the reported amount of time, and a cause could not be related to manufacturing activities.With the available information, the most probable root cause could be considered that the leak could be caused due to excessive force, sharp objects or due to an inappropriate use of cleaning agents.No corrective or preventive actions are required at this moment.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.This complaint will be used for tracking and trending purposes.

• Brand Name: 36CM PERM CATH KIT 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 ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5202409
• MDR Text Key: 30610575
• Report Number: 3009211636-2015-00445
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 219403X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 82 YR