MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD BC 22 GA 1 INCH; BD INFUSION THERAPY SYSTEM

Catalog Number 382523

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/20/2018

Event Type  malfunction  

Event Description

Pt was not harmed, but had to have a second stick.

• Brand Name: BD INSYTE AUTOGUARD BC 22 GA 1 INCH
• Type of Device: BD INFUSION THERAPY SYSTEM
• Manufacturer (Section D): BD
• MDR Report Key: 7663466
• MDR Text Key: 113308166
• Report Number: MW5078238
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 382523
• Device Lot Number: 8004515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1