MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; INTRODUCER, CATHETER

Model Number	IPN036335
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Discoloration of distal tip of cordis.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 15224744
• Report Number: 15224744
• Device Sequence Number: 5851665
• Product Code: DYB
• UDI-Device Identifier: 10801902112962
• UDI-Public: (01)10801902112962
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• Report Date (Section F): 07/25/2022

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
• Device Model Number: IPN036335
• Device Catalogue Number: ASK-21242-VCU
• Device Lot Number: 13F22D0706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2022