MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/19/2022

Event Type  Injury  

Event Description

Terumo medical received fda medwatch report #mw5109513.The event description states that the patient underwent an ultrasound guided placement of the iv catheter, when the iv was discontinued the hub was only present.There was no catheter.A chest cat scan revealed a retained portion had traveled to the pulmonary artery.A plan for retrieval in the operating room is on date of scheduled procedure.The retained device could not be visualized, and the procedure was cancelled.On (b)(6) 22 the patient underwent a heart transplant during the procedure, there was an incidental finding of the retained device which was removed without patient impact by the surgeon.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; biñan, ; *
• MDR Report Key: 18561368
• MDR Text Key: 333433923
• Report Number: 2243441-2023-00055
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2022,01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SR-OX2051CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2022
• Distributor Facility Aware Date: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other