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 Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2022

Event Type  Injury  

Event Description

Terumo medical received fda medwatch report # mw5109510.The event description states: that during the removal of an iv, the catheter portion fractured.An ultrasound was performed.The findings consistent with the retained catheter in the right basilic vein.The patient required invasive procedure for removal.Additional information was received 16 jun 2022: there was no procedure performed for the patient prior to the catheter being removed.The iv had been placed approximately six (6) days prior to removal.It is unknown if there was difficulty placing the catheter in the patient's vein.There was no leakage noted during the time of placement and it was not noted if there was leakage on the cover bandage at time of removal.The iv had already been fractured when the bandage was removed.It was not noted if the catheter became fractured during removal.Surgical intervention was required, and the fractured catheter fragment was successfully removed from the patient.The patient condition was stable at the time of the event.The catheter fragment was found in the basilic vein was about 1.8 inches.The facility is not new to using this specific product.

• 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: 18561370
• MDR Text Key: 333435453
• Report Number: 2243441-2023-00054
• 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: 06/24/2022,01/23/2024

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: 06/24/2022
• Distributor Facility Aware Date: 05/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2022
• 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): Required Intervention