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

Catalog Number 382523

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Event Description

Regarding bd insyte autoguard bc 22 gauge 1 inch needles.Piv placed and iv catheter hub did not luer lock into iv extension tubing properly.Iv leaking at this connection site despite changing iv extension tubing.Unable to infuse medication, needed to remove iv to place another patent iv.Patient is a difficult iv start and we were unable to establish another piv at the time and patient needed to be rescheduled.

• Brand Name: INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12466686
• MDR Text Key: 271285824
• Report Number: 12466686
• 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
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382523
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 77