MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEM, INC. NEXIVA CLOSED IV CATHETER SYSTEM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Catalog Number 383536

Device Problems Positioning Failure (1158); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

The iv catheter simply did not deploy either inside or outside of the patient.The needle never advanced so no sharp ever reached the pt.The nurse got a new catheter and successfully started the iv.Patient is without complications to the iv site; no patient injury.The catheter was packaged up to be sent back to product manufacturer.

• Brand Name: NEXIVA CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEM, INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 4931111
• MDR Text Key: 6050342
• Report Number: 4931111
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/09/2015

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: Nurse
• Device Catalogue Number: 383536
• Device Lot Number: 5100616
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 54