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

Catalog Number 383536

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

Patient admitted to emergency department after a fall that happened in her home.Bd nexiva closed iv catheter system was inserted into patient and connected to an iv pump.Iv pump alarmed "down-stream occlusion" when nurse was trying to infuse ns.She pulled back on the saline lock and the pump would flow again.After she walked out of the room, the pump would alarm again with the same message.She changed iv pumps thinking that would solve the problem but decided this was attributed to the positioning of the catheter.The patient was then sent to ct and the iv was connected to the power injector.During the test flush the pressure alarm sounded on the power injector.Pressure settings were decreased from the normal 3 cc/sec to 1.5 cc/sec.The ct tech then stood by the iv during injection.The alarm again sounded and when the tech looked the majority of the contrast had leaked out onto the floor and the tubing had expanded.The procedure was stopped and an er cct was called to remove the iv and start another one.The patient was not harmed, did not get any contrast on her, and the iv site showed no signs of infiltration (no redness, swelling, tenderness).The iv tubing was saved but the packaging was already discarded by this point.The staff believe the problem is with the closed catheter system tubing, not the tubing, pump, or injector the system was connected to.

• Brand Name: BD NEXIVA CATHETER SYSTEM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.; 9450 south state street; salt lake city UT 84070
• MDR Report Key: 4931141
• MDR Text Key: 6028330
• Report Number: 4931141
• 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

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 07/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Patient Sequence Number: 1
• Treatment: CONTRAST INJECTOR.
• Patient Age: 83 YR