MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROWGARD BLUE MAC; TWO LUMEN CENTRAL VENOUS ACCESS CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 09/10/2019

Event Type  Death  

Event Description

The pa catheter was discontinued from the two lumen central venous access catheter.Two hours later, the pt coded and bleeding was noted existing the introducer.

• Brand Name: ARROWGARD BLUE MAC
• Type of Device: TWO LUMEN CENTRAL VENOUS ACCESS CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL; reading PA
• MDR Report Key: 9329411
• MDR Text Key: 166767728
• Report Number: 9329411
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Distributor Facility Aware Date: 09/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2019
• 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): Death
• Patient Age: 81 YR