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

Lot Number 0216672

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  malfunction  

Event Description

A 20 gauge iv catheter needle retraction buttons have been failing.Fda safety report id # (b)(4).

• Brand Name: BECTON DICKINSON INFUSION THERAPY SYSTEMS INSYTE AUTOGAURD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 10884727
• MDR Text Key: 217963414
• Report Number: MW5098022
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814343
• UDI-Public: (01)00382903814343
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/19/2020

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: Health Professional
• Device Lot Number: 0216672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2020
• 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