MAUDE Adverse Event Report: COSTA RICA 36CM PERM CATH KIT X5; DIALYSIS CATHETER

Model Number 8817748001

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer stated that after catheterizing the patient on (b)(6) 2014, there was blood oozing from the joint of arterial and venous adapters during the dialysis process.So the dialysis treatment was halted.The catheter was pulled and replaced with a new one the following day.Patient recovered without further issues.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There are no non-conformances related to the reported issue.The product sample consisted of two adapters.One adapter corresponds to the arterial adult adapter and the other to the venous adapter.After a visual inspection, a crack on the thread region of the adapters was identified.As per 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.Overtightening catheter connections can crack the adapters.The device was more likely damaged during use.The most probable root cause can be due to over tightening of the adapter.A corrective action is not warranted 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 non-conforming 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.

• Brand Name: 36CM PERM CATH KIT X5
• 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: 4276376
• MDR Text Key: 5005172
• Report Number: 3009211636-2014-00177
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 030215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• 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