MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNKNOWN DIALYSIS

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; 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.During a literature review for a study of patients between december 2009 and june 2015, the customer states it was found that there were catheter related complications while using the argyle swan neck curl catheters.There were 9 catheter occlusions, 4 cuff extrusions, 4 catheter leakage, and 6 catheter migration.

Manufacturer Narrative

The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.As no lot number was identified, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event, however, the following potential causes were identified: user error, improper handling techniques during placement, malfunction, inspection not performed, defective material, too little glue used, too much glue used, user excessive force or jerking motion, operator mis-execution, or misuse.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.More information was requested to the customer and no additional evidence was provided for this analysis.This complaint will be reopened and updated accordingly if the product sample is returned or if additional information becomes available.The catheter is assembled manually, according to relevant formula sheet.100% visual inspection for nicks, cuts or blemishes that do not meet drawing specifications take place at the finale stage of production as per manufacturing procedure.Qa sampling inspection is performed.In addition, this catheter is subject to a sterilization cycle.The evidence provided is not enough to relate this event to the manufacturing operations.Additionally, there are a number of alternatives on the field like exposure to contaminating agents, or manipulation per se that may the cause failures reported.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 performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: DIALYSIS UNKNOWN
• 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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5812275
• MDR Text Key: 50964666
• Report Number: 3009211636-2016-00323
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN DIALYSIS
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 07/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1