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

Model Number 8888145049

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that customer had an issue with a dialysis catheter.The customer states that a leak was found in y-junction.As the result, the patient experienced blood leakage.The catheter was implanted in the patient in (b)(6) 2012.The device was pulled and replaced on (b)(6), 2014.No patient injury.The dwell time of the catheter in the patient: 1 year with 10 months.

Manufacturer Narrative

Submit date: 09/08/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The returned product sample consisted of one palindrome sapphire 28/45kt vt catheter.After visual inspection, a hole could be appreciated on the joint between the catheter and the hub.During underwater test (functional test), bubbles were detected coming out below the hub from lumen which corresponds to the venous extension.The lumen corresponding to the arterial extension did not showed bubbles during the test.All the possible causes were identified.No lot number was provided, therefore, it is not possible to perform a dhr review.This defect has been confirmed.Based on the available information, the probable root cause can be considered as misuse (leak could be caused more likely due to over bending or excessive force).Per procedure, manufacturing performs 100% pressure 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 28/45KT VT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUFACTURING; alajuela, cr 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; alajuela 2010 1; CS 20101
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4232056
• MDR Text Key: 4973416
• Report Number: 3009211636-2014-00071
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145049
• Device Catalogue Number: 8888145049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1