MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEM, INC. BD INSYTE; AUTOGUARD BC

Catalog Number 382533

Device Problems Break (1069); Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 08/09/2018

Event Type  malfunction  

Event Description

On first attempt, iv catheter bent when being advanced.Vein blew.Upon inspection of the angiocath, it appeared damaged near the end of the tube.On second attempt, vein appeared to blow while trying to advance the catheter.When catheter was removed and inspected, the end of the hub appeared to have been spitting.

• Brand Name: BD INSYTE
• Type of Device: AUTOGUARD BC
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEM, INC. ; sandy UT 84070
• MDR Report Key: 7784411
• MDR Text Key: 117292090
• Report Number: MW5079150
• 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: 08/13/2018

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 382533
• Device Lot Number: 8102501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2018
• 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
• Patient Age: 34 YR
• Patient Weight: 87