MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW PRESSURE INJECTABLE ARROWG+ARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	IPN037306
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Nausea (1970); Convulsion/Seizure (4406)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc line insertion.Case proceeded normally until line was in superior vena cava.While positioning the last few cm, patient stated he was feeling nauseous.Patient felt the need to urinate.Patient then began having seizure like movements.Patient became unresponsive.Procedure aborted.Code blue called.Discovered to be an allergic reaction to the chlorehexidine.

• Brand Name: ARROW PRESSURE INJECTABLE ARROWG+ARD
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 16494835
• Report Number: 16494835
• Device Sequence Number: 6239569
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: (01)50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/24/2023
• Report Date (Section F): 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F22L0485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2023
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 02/24/2023