MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX19.5CM MAHURKAR; DIALYSIS CATHETER

Model Number 8813793009

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 9/16/2016.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 reports the venous hole (blue) cannot flow when it was tested with normal saline.There was no patient involved.

Manufacturer Narrative

Submit date: 2/7/2017.A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The product sample was returned to the manufacturing site for evaluation; it consisted in one guide wire and one 11.5 mahurkar catheter.These components were returned inside a generic plastic bag and the catheter did not showed signs of use in a patient.Visual inspection was performed and the catheter did not reveal visual defects.In order to confirm the issue reported, the guide wire was passed through both extensions; as result the guide wire passed easily through the arterial extension, however guide wire did not pass through the hub in the venous lumen.The catheter was cut and it was observed that the hub was partially obstructed with a kind of resin inside the venous lumen.Based on previous analysis it can be concluded that the most possible root cause for the hub occlusion is related to manufacturing operations activities.Current method does not control, the time the swab stick is submerged in the solvent and how much solvent is applied to the hub.This complaint is considered a reportable manufacturing related event; a qseas session was performed and leverage to the capa (b)(4) was performed.No further actions are required.It must be noted that in-process controls as visual inspection and pressure test (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: KIT 11.5FX19.5CM MAHURKAR
• 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 st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5956268
• MDR Text Key: 55212429
• Report Number: 3009211636-2016-00394
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 1514000101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1