MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383539

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 09/03/2019

Event Type  malfunction  

Event Description

When starting iv the nexiva catheter did not come apart from the catheter as normal.2 other rns entered the room and after some attempts at wiggles and pulling at needle, they finally were able to get the 2 pieces to come apart.

• Brand Name: BD NEXIVA, BD Q-SYTE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 9109074
• MDR Text Key: 159774138
• Report Number: 9109074
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/10/2019

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 Model Number: 383539
• Device Catalogue Number: 383539
• Device Lot Number: 9162759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1