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

Model Number	IPN036445
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Central line ballooned out while it was inserted in the patient.

• 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: 15257924
• Report Number: 15257924
• Device Sequence Number: 20510909
• Product Code: FOZ
• UDI-Device Identifier: 10801902116793
• UDI-Public: (01)10801902116793
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/11/2022
• Report Date (Section F): 08/11/2022

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: IPN036445
• Device Catalogue Number: CDC-15703-P1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 08/11/2022