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

Model Number	383593
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.The caregiver was able to tamponed the vein and remove the catheter assembly with only a few cc blood loss.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, bd nexiva diffusics (per site reporter).Waiting for their investigation results.
Event or Problem Description
Bd nexiva diffusics 20 ga x 1.25 in closed iv catheter system.The pre-attached extension tubing dislodged from the stabilization platform after starting the iv on the patient.The caregiver was able to tamponed the vein and remove the catheter assembly with only a few cc blood loss.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, bd nexiva diffusics (per site reporter).Waiting for their investigation results.

• Brand Name: BD NEXIVA DIFFUSICS
• Common Device Name: 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: 20673744
• Report Number: 20673744
• Device Sequence Number: 8941076
• Product Code: FOZ
• UDI-Device Identifier: 00382903835935
• UDI-Public: (01)00382903835935
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024
• Report Date (Section F): 10/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 383593
• Device Catalogue Number: 383593
• Device Lot Number: 4124921
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/16/2024