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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that when removing the involved iv, it was noticed that the catheter was still in the patient, it separated.The patient went home in good condition.The patient had to be taken or for removal of the catheter tip.The patient was in stable condition and was discharged.The blood loss was less than 250cc's.The event occurred intra-operative.Additional information was received on 30 dec 22: the or reported that the procedure was successful.It was unknown if testing was performed to ensure the tip was removed entirely.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; biñan, ; *
• MDR Report Key: 18561369
• Report Number: 2243441-2023-00056
• Device Sequence Number: 20862316
• Product Code: FOZ
• UDI-Device Identifier: 34806017510160
• UDI-Public: 34806017510160
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024
• Report Date (Section F): 01/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: SR-OX1651CA
• Device Lot Number: 191204D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/23/2023