CELSITE ACCESS PORT

Report

• Report Number: 3006332832-2016-00005
• Event Type: Injury
• Date Received: December 15, 2016
• Date of Event: March 31, 2016
• Report Date: December 14, 2016
• Manufacturer: B. BRAUN MEDICAL SAS
• Product Code: LJT
• Adverse Event: Yes
• Product Problem: Yes
• Report Source: Distributor report
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

PATIENT'S FAMILY CONTACTED B. BRAUN INTERVENTIONAL SYSTEMS TO REPORT THE FRAGMENT OF A PORT CATHETER SEVERING AND MIGRATING TO RIGHT ATRIUM, WHICH WAS SUCCESSFULLY RETRIEVED. PATIENT HAD PORT DUE TO DIAGNOSIS OF CANCER. SHORTLY AFTER DISCHARGE PATIENT FELT LIKE SOMETHING MOVED IN HER CHEST AND BEGAN EXPERIENCING CHEST PAINS. PATIENT RETURNED TO IMPLANTING HOSPITAL AND WAS TOLD THAT PAINS WERE ASSOCIATED WITH PORT "SETTLING IN" AND WAS SENT HOME. CHEST PAINS PERSISTED, PATIENT WENT TO SECOND HOSPITAL WHERE THEY PERFORMED CHEST X-RAY AND DETERMINED A PIECE OF THE PORT CATHETER BROKE OFF AND WENT INTO HEART. CATHETER SEGMENT WAS RETRIEVED PERCUTANEOUSLY THROUGH JUGULAR VEIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
829996	CELSITE ACCESS PORT	CELSITE ACCESS PORT	LJT	B. BRAUN MEDICAL SAS		K137685U

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization| L| R| S

Terms

Patient problem · 1

• Foreign Body In Patient

Product problems · 1

• Material Separation

Type of report · 1

• Initial submission