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

Model Number 382533

Patient Problems Pain (1994); Needle Stick/Puncture (2462)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Iv catheter tip dull.Healthcare provider had to re-stick patient, due to not being able to poke thru the skin.This issue has been causing additional sticks and unnecessary pain for the patient.Catheter was discarded.Lot# 3251082 exp: 08-31-2026 20g autoguard.

• 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: 18738160
• MDR Text Key: 335741012
• Report Number: 18738160
• 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: 01/08/2024

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
• Device Operator: Health Professional
• Device Model Number: 382533
• Device Catalogue Number: 382533
• Device Lot Number: 3251082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/08/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1