MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA, BD Q-SYTE; IV CATHETER

Model Number 383537

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

The bd nexiva iv caths 20 x 1.25 bd # 383537, lot # 9010686 have loose caps.If the nurse does not notice that it is loose, there will be a blood spill.They looked at their packages and found 17 of this same lot # that were like this.Lawson # is 305872.They had a blood spill in the emergency department today because of this.

• Brand Name: BD NEXIVA, BD Q-SYTE
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8623485
• MDR Text Key: 145495198
• Report Number: 8623485
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383537
• Device Catalogue Number: 383537
• Device Lot Number: 9010686
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1