MAUDE Adverse Event Report: COVIDIEN PALINDROME SAPPHIRE 28/45KT VT; DIALYSIS CATHETER

Model Number 8888145049C

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

It was reported to covidien (b)(4) 2014 that customer had an issue with a dialysis catheter.The customer states that there was a leak at the y-juction.As a temporary fix, the physician put glue on the catheter crack.The catheter was initially placed on (b)(6) 2013.The catheter was pulled and replaced on (b)(6) 2014.

Manufacturer Narrative

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

Event Description

The returned product sample consisted of one assembled catheter palindrome which presented signs of usage (blood residues).The possible causes were identified.No lot number was provided, therefore, it is not possible to perform a dhr review.None of the complaints have been confirmed manufacturing related issues.During visual inspection, a hole could be appreciated on the catheter just below the hub.During underwater test (functional test), bubbles were detected coming out below the hub.This defect has been confirmed.Based on the available information, the probable root cause can be considered most likely as misuse (leak could be caused due to over bending or excessive force).No additional action is 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 nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs 100% pressure testing at the final stage of production, which would identify a leak in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PALINDROME SAPPHIRE 28/45KT VT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; 5439 state route 40; argyle NY 12809
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela NY 12809
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 3823085
• MDR Text Key: 4447509
• Report Number: 1317749-2014-00212
• Device Sequence Number: 1
• Product Code: MPB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145049C
• Device Catalogue Number: 8888145049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR