MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. INTROCAN SAFETY IV CATHETER -FEP; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 4252527-02

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2024

Event Type  Injury  

Event Description

Peripheral right radial arterial catheter placed in the operating room on (b)(6) 2024.On (b)(6) 2024, the right radial arterial catheter was discontinued.Upon removal, the catheter dislodged from the catheter hub and remained in the arterial vessel.Required return to operating room for right radial arterial foreign body's successful removal.Upon removal of the radial arterial catheter, the catheter dislodged from the catheter hub.Ultrasound of the right radial artery demonstrated the presence of a pliable plastic cylindrical foreign body in the arterial vessel measuring 4.9 cm length x 0.1 cm diameter.

• Brand Name: INTROCAN SAFETY IV CATHETER -FEP
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 19152572
• MDR Text Key: 341001073
• Report Number: MW5154038
• 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: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: 4252527-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American