MAUDE Adverse Event Report: COSTA RICA PALINDROME SAPPHIRE 23/40KT VT; DIALYSIS CATHETER

Model Number 8888145048

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2014

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 states that there was a leak in hub.Therefore, the patient experienced blood leakage.The catheter was implanted on (b)(6) 2012.The catheter was replaced on (b)(6) 2014.No patient injury, date of incident: (b)(6) 2014.Dwell time of the catheter into the patient: 2 years with 6 months.

Manufacturer Narrative

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

Manufacturer Narrative

The manufacturing lot number associated with this complaint was not provided.Without the lot number, a device history record (dhr) review could not be performed.All dhrs are reviewed for accuracy prior to product release.The product sample consisted of one 14.5 fr dual lumen hemodialysis catheter, palindrome with laser slots, heparin coating and an anti-microbial sleeve.The catheter presented signs of use and was cut under the felt cuff.After a visual inspection, a hole was found on the joint of the catheter, between the hub and the am sleeve.During a functional test (underwater test), bubbles were detected coming out from below the hub, from the lumen which corresponds to the arterial extension.The lumen corresponding to the venous extension did not show bubbles during the test.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 device was in use for 2 years and 6 months.The device was more likely damaged during use.As part of a corrective and preventative action, catheter and cleaning information was collected from the customer.The most probable root cause can be due to improper use of a cleaning agent.Whenever alcohol is used, be sure to allow two minutes for drying.Ensure the hub area is dry prior to dressing the exit site and or catheter back end.Be sure to leave the hub and hub joint exposed [do not cover with dressing].The device involved in this event was manufactured before the implementation date of actions related to a corrective and preventative action.It was defined that this event is being handled through this capa and no additional actions are required.No additional actions are required.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% leak testing at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME SAPPHIRE 23/40KT VT
• 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: 4224071
• MDR Text Key: 4976181
• Report Number: 3009211636-2014-00144
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2014

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: 8888145048
• Device Catalogue Number: 8888145048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 11/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• 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
• Patient Age: 67 YR