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

Model Number 382534

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

The iv catheter needle went through the catheter and did not retract (no one was injured).The team shared that this has happened before.There is also concern that they are "sticking" and not retracting so we have asked team members to start entering verge events and place the needle and packaging in a sharps container.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: 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: 16434939
• MDR Text Key: 310146049
• Report Number: 16434939
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382534
• Device Catalogue Number: 382534
• Device Lot Number: 2053116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1