MAUDE Adverse Event Report: COSTA RICA ***KIT 28CM PERMCATH; DIALYSIS CATHETER

Model Number 8834369001

Device Problem Crack (1135)

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

Event Date 10/14/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a dialysis catheter.The customer states that they found blue adapter of the catheter was cracked prior to start haemodialysis treatment.There was blood leakage from the catheter where connected to patient.The catheter was implanted on (b)(6) 2013.The catheter was replaced with a new one.

Manufacturer Narrative

Submit date: 11/04/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

All dhrs are reviewed for accuracy prior to product release.The product sample returned was received within a generic plastic bag.It consisted of one permcath catheter.After visual inspection, the blue adapter was found broken at the top.The photo provided by the customer also shows a blue adapter broken at the top.Based on the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.Over tightening the catheter connections can crack some adapters.Based on the event description, the device functioned as intended for more than a year.It can be concluded that the adapter was more likely damaged during use.The most probable root cause is over tightening the adapter, causing the crack.There are no additional actions required at this time.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 in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual inspection during production, which would identify cracked adapters in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COSTA RICA; 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: 4224218
• MDR Text Key: 4972069
• Report Number: 3009211636-2014-00146
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 10/16/2014

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: 8834369001
• Device Catalogue Number: 8834369001
• Device Lot Number: 206129X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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