MAUDE Adverse Event Report: BD NEXIVA; NEXIVA IV SALINE LOCK

Lot Number 5264819

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/26/2015

Event Type  malfunction  

Event Description

Upon removal of the iv saline lock, part of the iv was still visible in pt's arm.Saline lock did not remove in one complete piece.Add'l piece of iv, measuring about an inch in size, removed using suture removal kit tweezers and was inspected to reinsure it was the complete end of the catheter.Final end of catheter was noted to have a round, smooth and without any sharp edges noted.

• Brand Name: NEXIVA
• Type of Device: NEXIVA IV SALINE LOCK
• Manufacturer (Section D): BD; research triangle park NC 27709
• MDR Report Key: 5341231
• MDR Text Key: 35057430
• Report Number: MW5058842
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2015

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 Expiration Date: 08/31/2018
• Device Lot Number: 5264819
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR