MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA DIFFUSICS; CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM

Device Problem Insufficient Information (3190)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888)

Event Date 01/20/2018

Event Type  Injury  

Event Description

A (b)(6) seen in ed and found to have splenic hemorrhage.A 20 g diffusics catheter to right forearm was placed.Pt was taken emergently to operating room.Received normal saline and blood products through right iv site.After procedure, right arm was untucked from drape and found to have significant extravasation.Underwent right forearm fasciotomy for compartment syndrome.

• Brand Name: BD NEXIVA DIFFUSICS
• Type of Device: CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON; sandy UT 84070
• MDR Report Key: 7237757
• MDR Text Key: 98993913
• Report Number: MW5075018
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 57