MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX16 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8830415003

Device Problem Failure to Advance (2524)

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

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/28/2016.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 during flushing of the venous side of the catheter, it passed-through, but during catheter insertion by the guide wire, the venous path can be inserted to a length of approximately 5cm only.The catheter was impassable.The catheter was not inserted into the patient.

Manufacturer Narrative

The lot number associated with this complaint was reviewed and no issues related to the reported condition were identified during manufacturing.The product sample was returned for evaluation and consisted of one catheter inside a generic plastic bag and did not show any signs of use.Visual inspection was performed and no defects were identified.Functional testing included passing a guide wire through both extensions.The wire passed easily through the arterial extension, however did not pass through the hub in the venous lumen.The catheter was cut and revealed that the hub was partially obstructed.Based on the information received, the root cause can be attributed to an excess of solvent applied to the hub during the manufacturing process.A corrective and preventive action (capa) has been initiated to address this issue.

• Brand Name: KIT 11.5FX16 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6128553
• MDR Text Key: 61203449
• Report Number: 3009211636-2016-00472
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 11/04/2016

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: 8830415003
• Device Catalogue Number: 8830415003
• Device Lot Number: 1616500094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR