MAUDE Adverse Event Report: COSTA RICA PC PALINDROME 19/36 KIT W/SLOT; DIALYSIS CATHETER

Model Number 8888145058

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/31/2014

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 the patient was catheterized on (b)(6) 2014, then on (b)(6) 2014, (half a year later) there was blood leakage near the cuff.The catheter was pulled and replaced with a new one.

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 a 14.5 fr palindrome pre-curved with slots catheter with signs of use.After a visual inspection, 3 different cuts were identified on the silicone tubing, approximately at 0.5 cm above the cuff and approximately at 5 cm below the cuff.As per the instructions for use, it is necessary to visually inspect the device before use.Do not use the catheter if it appears damaged or defective.Exercise caution when using sharp instruments near the catheter.The catheter tubing can tear when subjected to nicks, excessive force or rough edges.Inspect the catheter frequently for nicks, scrapes or cuts which could impair its performance.The device was used for approximately 6 months.The device was more likely cut during use.The most probable root cause could be due to inappropriate use of sharp objects.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% 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: PC PALINDROME 19/36 KIT W/SLOT
• 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: 4245572
• MDR Text Key: 5016879
• Report Number: 3009211636-2014-00157
• 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: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145058
• Device Catalogue Number: 8888145058
• Device Lot Number: 221507X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• 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