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

Model Number 382544

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Nurse using 18g angio catheter to start iv.Nurse gained access with blood return, but as catheter was threaded, it folded completely in half at point of insertion.Intact catheter removed and discarded.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 16371165
• MDR Text Key: 309485795
• Report Number: 16371165
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382544
• Device Catalogue Number: 382544
• Device Lot Number: 2199879
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1