MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROWG+ARD BLUE CENTRAL VENOUS CATHETER (CVC); CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Patient Problems Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 01/03/2024

Event Type  Injury  

Event Description

Intraoperatively, after placement of the central line catheter, the patient did have an allergic reaction and developed tachycardia with hypotension.Patient did receive epinephrine boluses and a drip.Did become stable and continued on with procedure.

• Brand Name: ARROWG+ARD BLUE CENTRAL VENOUS CATHETER (CVC)
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 18589908
• MDR Text Key: 333961205
• Report Number: MW5150790
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White