MAUDE Adverse Event Report: COVIDIEN MAHURKAR 13.5FRX13.5CM PC KIT; DIALYSIS CATHETER

Model Number 8888135133

Device Problems Hole In Material (1293); Defective Device (2588)

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

Event Date 02/21/2015

Event Type  malfunction  

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 on (b)(6) 2015 a patient was prepared for a mahurkar jugular catheter placement.All the equipment was prepared to perform this procedure, catheter was permeated with saline, internal jugular puncture was performed obtaining venous access, the catheter was placed without complications.The doctor was trying out the permeabilization and found a defect of the catheter, he saw blood derivatives coming out through a small hole in the venous extension tubing, so it was removed and x-rays were taken to monitor that there were no hematomas and the patient was left in observation.The procedure to place a new catheter was scheduled to be done on (b)(6) 2015 with puncture guide at the angiography service.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter or components if they appear 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.The most probable root cause could be due to excessive force.A corrective action is not warranted at this time.It must be noted that in-process controls (such as personnel training, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.Per procedure, 100% extensions visual inspection is conducted by manufacturing, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: MAHURKAR 13.5FRX13.5CM PC KIT
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4647513
• MDR Text Key: 5614039
• Report Number: 3009211636-2015-00182
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135133
• Device Catalogue Number: 8888135133
• Device Lot Number: 322743X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1