MAUDE Adverse Event Report: UNKNOWN CENTRAL VENOUS CATHETER (CVC); CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Patient Problems Infiltration into Tissue (1931); Pain (1994); Swelling/ Edema (4577)

Event Date 11/28/2023

Event Type  Other  

Event Description

An inappropriate cvc device was placed and the tip of the line did not/does not terminate in the svc or near/ in the right atrium.A dangerous event occurred as tpn was infused via the inappropriate and inappropriately placed cvc.The patient developed considerable swelling of the neck, shoulder and chest area.The tpn infiltrated into the patient, rather than flow correctly through the bloodstream.Error occurred as an inpatient in hospital.Patient awoke in a.M.With swelling of neck, chest and shoulder and severe pain.Patient reported situation to nursing staff.Hospital, nursing staff and supposed physician who placed the cvc line, and were aware of the location of the tip/end of cvc line insisted that tpn infusion does not require a full and appropriate cvc device terminating in / near right atrium or in the svc is fine and not dangerous.Despite the harm done to patient.Cvc line should have been placed in the correct position to begin with.Nursing and medical staff should have known that infusing tpn through a central line that does not terminate in the svc would lead to dangerous events and unsafe infusion.(b)(6).

• Brand Name: CENTRAL VENOUS CATHETER (CVC)
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18365752
• MDR Text Key: 331194308
• Report Number: MW5149417
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/30/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Patient Sequence Number: 1