MAUDE Adverse Event Report: BD BD INSYTE - AUTOGUARD

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2017

Event Type  Injury  

Event Description

Catheter broke off and was retained in left arm.A surgical procedure was required to retrieve fragment of catheter.

• Brand Name: BD INSYTE - AUTOGUARD
• Type of Device: BD INSYTE - AUTOGUARD
• Manufacturer (Section D): BD
• MDR Report Key: 6830451
• MDR Text Key: 84243139
• Report Number: MW5071833
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/25/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 97