MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383536

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use blood leakage occurred from hole in tubing with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: customer started an iv on a patient and when she added this catheter, blood began to leak out of the line.After removing.Staff was exposed to blood but was wearing ppe.

Event Description

It was reported that during use blood leakage occurred from hole in tubing with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: customer started an iv on a patient and when she added this catheter, blood began to leak out of the line.After removing.Staff was exposed to blood but was wearing ppe.

Manufacturer Narrative

H.6.Investigation summary : our quality engineer inspected the sample submitted for evaluation.Bd received one used unit without the needle assembly, vent plug, and top web.Through the visual examination, damage was observed to the tubing near the y adapter.A water/air leak test was performed and leakage was observed at the point of damage.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to gripper damage or misalignment.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9779294
• MDR Text Key: 185292064
• Report Number: 1710034-2020-00132
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835363
• UDI-Public: 30382903835363
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 383536
• Device Catalogue Number: 383536
• Device Lot Number: 9233236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other