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

Model Number	IPN033577
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A procedure by anesthesiologist was performed: insertion of a rapid infusion catheter into the left upper extremity using a guidewire.The patency of the iv was checked by ultrasound and flushed with saline.The following day, an x-ray the following confirmed the guidewire was retained and was seen in the left arm running along the left sided thoracic spine.The patient was taken to interventional radiology for removal.

• Brand Name: ARROW
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 9207711
• Report Number: 9207711
• Device Sequence Number: 10839292
• Product Code: DYB
• UDI-Device Identifier: 00801902001368
• UDI-Public: (01)00801902001368
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2019
• Report Date (Section F): 09/30/2019

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 Model Number: IPN033577
• Device Catalogue Number: RC-09700
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/30/2019