MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX13.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813817009

Device Problem Partial Blockage (1065)

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

Event Date 08/20/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 8/24/2016.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 line (blue color) of the catheter is blocked and the guide wire was stuck in the catheter and insertion was not possible.This was found during the insertion of catheter in the patient and had to be replaced with a fresh catheter to be placed in the patient.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.A visual inspection was performed and the catheter did not reveal any visual issues.The guide wire was passed through both extensions.The guide wire passed through the arterial extension but it could not pass through the venous extension.The hub of the venous extension was obstructed and the orifice looked smaller.A resin was also found on the venous lumen.The hub was partially occluded due to an excess of dimethylacetamide during the gluing process.A formal corrective and preventative action was opened and additional actions are not required.It must be noted that in-process controls, according to procedure (such as personnel training, incoming quality acceptance testing for (b)(4), 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.

• Brand Name: KIT 11.5FX13.5 CE 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 street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5899761
• MDR Text Key: 54029279
• Report Number: 3009211636-2016-00357
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813817009
• Device Catalogue Number: 8813817009
• Device Lot Number: 1522400144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1