MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	IPN036437
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The introducer needle slides off the syringe if gel or blood gets on it.The introducer needle does not stay stationary when place on the syringe.

• Brand Name: ARROW
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 19003007
• Report Number: 19003007
• Device Sequence Number: 12877856
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: (01)20801902117216
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/24/2024
• Report Date (Section F): 01/24/2024

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: IPN036437
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F23G0429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• 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: 01/24/2024