MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	IPN036260
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient arrived from the operating room and the swan was working in obtaining pa pressures, but nursing staff were unable to obtain any co/ci numbers.On closer inspection they found blood oozing out of the wiring port that connects the swan to the monitor, the beige port on the yellow lumen of the swan.The swan was then removed where all the components were intact, before being replaced with a new one by the overnight surgical icu physician.The malfunctioned swan was placed into a specimen bag and given to sicu manager.

• Brand Name: ARROW
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 17919448
• Report Number: 17919448
• Device Sequence Number: 15154605
• Product Code: DQO
• UDI-Device Identifier: 10801902121346
• UDI-Public: (01)10801902121346(17)251231(10)14F20MO153
• 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): 08/22/2023
• Report Date (Section F): 08/22/2023

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
• Device Model Number: IPN036260
• Device Catalogue Number: ST-09875
• Device Lot Number: 14F20MO153
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2023
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 08/22/2023