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

Model Number 382523

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2016

Event Type  malfunction  

Event Description

Upon opening insyte packaging, staff found that the sheath was damaged with a small piece of plastic hanging on to it.This insyte was not used on a patient.

• Brand Name: INSYTE AUTOGUARD BC
• Type of Device: SHIELDED IV CATHETER
• Manufacturer (Section D): BD; sandy UT 84070
• MDR Report Key: 5815122
• MDR Text Key: 50324928
• Report Number: MW5063594
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 382523
• Device Lot Number: 6096765
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1