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

Model Number 8888145048

Device Problem Insufficient Information (3190)

Patient Problem Purulent Discharge (1812)

Event Type  Injury  

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 the catheter was placed on (b)(6) 2014.On (b)(6) 2014 there was puss at the exit site and the patient was treated with antibiotics (bactroban).

Manufacturer Narrative

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

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for evaluation; however, a photo was received.An infection of the patient¿s skin was observed at the exit site.The device was in use for approximately 10 months.Per the instructions for use, infection is a potential complication inherent to the medical procedures and has no direct relation with the performance of the device.A possible root cause may be due to the medical procedures conducted with the patient.A corrective action is not applicable 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.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): COVIDIEN; 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: 4483623
• MDR Text Key: 5565310
• Report Number: 3009211636-2015-00071
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888145048
• Device Catalogue Number: 8888145048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 111