MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA MAHURKAR KIT 13.5FRX16CM CE; DIALYSIS CATHETER

Model Number 8888135162

Device Problems Partial Blockage (1065); Difficult to Insert (1316); Material Deformation (2976)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 2/6/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer reports the catheter tip is closed and the guide wire cannot pass through the venous outlet of the catheter tip.

Manufacturer Narrative

Submit date: 03/15/2017.A device history record (dhr) review was performed to the reported lot.No discrepancies that may have contributed to a complaint of this nature were found.All dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed; the picture shows a guide wire in the catheter lumens, however it is not evident whether the tip of the catheter is open or closed.The defect could not be confirmed with the photo.Should a physical sample is received, this will be analyzed and its results will be included in this investigation.According to the visual evaluation of the picture, the catheter did not reveal a defect related to the reported condition.The provided photo was evaluated finding no defects related to the reported condition.Based on the available information, a confirmed cause related to manufacturing activities could not be established.At this point, the available information indicates that this product was manufactured according to specifications.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.

Manufacturer Narrative

Submit date: 2017-july-06 a device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.One photo was provided by the customer.Visual evaluation of this photo was performed.The picture shows a guide wire in the catheter lumens; however it is not evident whether the tip of the catheter is open or closed.Additionally one unused catheter was received for analysis and investigation.Visual inspection was performed and the catheter did not reveal visual issues.In order to confirm the reported condition, a guide wire from lab stock was used.It was passed through both extensions and as a result, the guide wire did not pass through the tip of the catheter.The catheters were cut and it was observed that the tip was partially obstructed with its same material.An ishikawa diagram was used to determine the potential causes for this event and possible causes were identified.The reported condition has been confirmed.Based on all gathered information, the most probable root cause for this event can be considered as manufacturing or supplier related.No complaint triggers or trends were identified.This complaint is considered as a fast track event since it is reportable and was confirmed as device related.Therefore, formal investigations, corrective and preventative action (capa) and supplier corrective action request (scar), have been opened to further investigate this issue and evaluate the controls that are in place during the manufacturing activities.The definitive root cause will be determined through these capa investigations.If further evidence becomes available, this complaint investigation will be reopened to be updated accordingly.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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien that a customer had an issue with a dialysis catheter.The customer reports the catheter tip is closed and the guide wire cannot pass through the venous outlet of the catheter tip.

• Brand Name: MAHURKAR KIT 13.5FRX16CM CE
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6304119
• MDR Text Key: 66867126
• Report Number: 3009211636-2017-00108
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135162
• Device Catalogue Number: 8888135162
• Device Lot Number: 1520900110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1