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

Model Number	IPN029818
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Guide wire would not pass through angiocath needle.Manufacturer response for catheter, percutaneous, arrow (per site reporter).

• Brand Name: ARROW
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2400 bernville road; reading PA 19605
• MDR Report Key: 9744576
• Report Number: 9744576
• Device Sequence Number: 16325584
• Product Code: DQY
• UDI-Device Identifier: 10801902144680
• UDI-Public: (01)10801902144680
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020
• Report Date (Section F): 02/14/2020

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: IPN029818
• Device Catalogue Number: ASK-00520-FAM
• Device Lot Number: 13F19F0426
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2020
• 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: 02/14/2020