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

Catalog Number 382523

Device Problems Backflow (1064); Leak/Splash (1354); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

After insertion, catheter has leaked, causing blood to back flow.The back flow valve seems to be defective, allowing blood to leak.

• Brand Name: INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10676952
• MDR Text Key: 211288207
• Report Number: 10676952
• 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: 09/23/2020

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: No Information
• Device Catalogue Number: 382523
• Device Lot Number: 0196770
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1