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 12/24/2022

Event Type  Injury  

Event 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
• 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: 18561369
• MDR Text Key: 333434193
• Report Number: 2243441-2023-00056
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 34806017510160
• UDI-Public: 34806017510160
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2023,01/23/2024

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-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
• Date Report Sent to FDA: 01/23/2023
• Distributor Facility Aware Date: 12/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male