MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. RADIAL ARTERY CATHETERIZATION SE, 20 GA 1 3/4; RADUAK ARTERY CATHETERIZATION

Model Number RA-04020

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

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

Event Date 05/24/2016

Event Type  malfunction  

Event Description

Package was sealed but empty.There was no product inside the package.Diagnosis or reason for use: establish arterial access on patient.

• Brand Name: RADIAL ARTERY CATHETERIZATION SE, 20 GA 1 3/4
• Type of Device: RADUAK ARTERY CATHETERIZATION
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA 19605
• MDR Report Key: 5690718
• MDR Text Key: 46392135
• Report Number: MW5062548
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00801902002730
• UDI-Public: (01)00801902002730
• 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: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: RA-04020
• Device Lot Number: 14F16B0756
• 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