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

Model Number 381412

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2022

Event Type  malfunction  

Event Description

Placing r foot 24g piv plus blood return.When i push the button to release the needle from the catheter, the entire catheter came out despite holding tamponade at site.The catheter itself shows no sign of blood flash, though the needle apparatus clearly has blood within it.Baby needed to be restuck.

• 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: 15224106
• MDR Text Key: 297890587
• Report Number: 15224106
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 381412
• Device Catalogue Number: 381412
• Device Lot Number: 1236824
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1