MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, FLOW DIRECTED

Model Number	IPN915244
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon would not deflate during testing.It did not get used on the patient.Eventually it deflated after it was replaced.There was no patient impact.

• Brand Name: ARROW
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10161939
• Report Number: 10161939
• Device Sequence Number: 19603701
• Product Code: DYG
• UDI-Device Identifier: 10801902160529
• UDI-Public: (01)10801902160529(17)210630(10)16F20B0022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2020
• Report Date (Section F): 06/16/2020

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: IPN915244
• Device Catalogue Number: AI-07126
• Device Lot Number: 16F20B0022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 73
• Date Report Sent to FDA: 06/16/2020