MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROWGARD CVC BLUE PLUS; CATHETER PERCUTANEOUS

Lot Number	13F17HO327
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
While inserting a central line the guidewire unraveled arrowgard blue plus multi-lumen cvs extreme kit #7 french /3 lumen/20 cm 0.032 inch spring wire lot # 13f17ho327 with ref # ak-45703-ax.

• Brand Name: ARROWGARD CVC BLUE PLUS
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 7340952
• Report Number: MW5075879
• Device Sequence Number: 1556344
• Product Code: DQY
• UDI-Device Identifier: 10801902119169
• UDI-Public: 0110801902119169
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Lot Number: 13F17HO327
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75