MAUDE Adverse Event Report: NAVILYST MEDICAL XCELA, NAVILYST MEDICAL; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number M00160M1613631

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

As reported, the hub of an indwelling picc separated from the extension tubing.This had also happened on 2 prior occasions (no date information available).There was no indication of patient injury or complications.It was indicated that one used picc would be returned to navilyst medical for evaluation.

Manufacturer Narrative

It has been indicated that the used catheter will be returned for evaluation, however it has not yet arrived.Upon receipt of the catheter and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

• Brand Name: XCELA, NAVILYST MEDICAL
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): NAVILYST MEDICAL; glens falls NY
• Manufacturer (Section G): NAVILYST MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4379106
• MDR Text Key: 5119696
• Report Number: 1317056-2014-00119
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/24/2014

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 Catalogue Number: M00160M1613631
• Other Device ID Number: XCELA PICC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/23/2014
• 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: Initial
• Patient Sequence Number: 1