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

Model Number	IPN035913
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The arrow arterial line catheter hub split after insertion and connection to pressure bag.The catheter was re-wired to a long teleflex catheter without problems and connected to the same pressure line.Patient was not harmed.

• Brand Name: ARROW
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12582974
• Report Number: 12582974
• Device Sequence Number: 1240238
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: (01)00801902027528
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/01/2021
• Report Date (Section F): 10/01/2021

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: Other
• Device Model Number: IPN035913
• Device Catalogue Number: RA-04020-SP
• Device Lot Number: 14F21E0113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 101
• Date Report Sent to FDA: 10/01/2021