MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD; INTRAVASCULAR CATHETER

Lot Number 8013892

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/22/2018

Event Type  malfunction  

Event Description

A 20 gauge iv cathlon inspected as usual and no visual defects noted.Iv started.As rn was advancing catheter, blood was dripping from small hole at base of cathlon.Iv had to be removed and restarted on pt.The cathlon causes iv fluids to infiltrate into the skin due to the hole being at the point the hub connects to the "straw." this occurred on another pt and the whole lot of cathlon's was pulled from stock.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD
• MDR Report Key: 7553109
• MDR Text Key: 109687754
• Report Number: MW5077500
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Lot Number: 8013892
• Is the Reporter a Health Professional?: Yes
• 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: 31 YR