MAUDE Adverse Event Report: BD INSYTE AUTOGUARD; SHIELDED IV CATHETER

Model Number 20 GA 1.16" / 1.1 X 30MM

Device Problem Positioning Failure (1158)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

Safety failed to deploy - no harm.Potential for harm.

• Brand Name: INSYTE AUTOGUARD
• Type of Device: SHIELDED IV CATHETER
• Manufacturer (Section D): BD; franklin lakes NJ 07417 188
• MDR Report Key: 4627972
• MDR Text Key: 15967583
• Report Number: MW5041587
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/17/2015

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: Other
• Device Expiration Date: 03/31/2017
• Device Model Number: 20 GA 1.16" / 1.1 X 30MM
• Device Catalogue Number: 382584
• Device Lot Number: 4255785
• Other Device ID Number: (01) 00382903825349
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1