FDA Adverse Event Malfunction Summary report: N

SMART PORT CT

MDR report key: 18290915 · Received December 8, 2023

Report

Report Number
18290915
Event Type
Malfunction
Date Received
December 8, 2023
Date of Event
July 19, 2023
Report Date
October 5, 2023
Manufacturer
NAVILYST MEDICAL, INC.
Product Code
LJT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT ARRIVED TO THE CLINIC TO RECEIVE CHEMOTHERAPY. PATIENT HERE FOR FOLFOX C4 D15. PATIENT AMBULATES TO INFUSION SUITE WITHOUT ASSISTANCE. IDENTITY CONFIRMED USING TWO PATIENT IDENTIFIERS: DOB AND FULL NAME. LABS WNL. PATIENT SEEN BY PROVIDER PRIOR TO TREATMENT. PORT ACCESS BY THIS REGISTERED NURSE (RN) WITH STERILE TECHNIQUES AS PORT WAS FLUSHED WITH NORMAL SALINE PATIENT GRIMACED DUE TO DISCOMFORT. PATIENT REPOSITIONED WITH SAME RESULTS. CHARGE NURSE AT CHAIRSIDE TO ASSESS PORT SITE. PATIENT AGAIN HAS DISCOMFORT WITH SALINE BEING PUSHED IN PORT. PORT DE ACCESSED WITH HUBER NEEDLE INTACT. FLUID NOTED COMING FROM PORT SITE. PORT RE ACCESSED. PATIENT STILL HAS DISCOMFORT AND SWELLING NOTED AROUND PORT SITE. PORT DE ACCESSED WITH HUBER NEEDLE INTACT. PLAN OF CARE EXPLAINED TO PATIENT AND QUESTIONS ANSWERED. PATIENT LEFT IN STABLE CONDITION AND SENT TO RADIOLOGY DEPARTMENT FOR FLUOROSCOPY. PATIENT HAD PORT REMOVED, DEEMED TO BE A MALFUNCTIONING PORT. NEW PORT IMPLANTED. PATIENT SEEN TO HAVE A NEW PORT IMPLANTED AFTER THE NEW PORT THAT WAS PREVIOUSLY INSTALLED. PATIENT AMBULATORY TO CLINIC FOR C5D15 FOLFOX. PATIENT IDENTITY CONFIRMED USING 2 IDENTIFIERS (NAME AND DOB), DENIES NEW COMPLAINTS. LABS AND ORDERS REVIEWED.  VS WNL.  IMPLANTED PAC L CHEST WITH SKIN INTACT; DERMABOND TO THE SITE. PORT ACCESSED PER PROTOCOL USING ASEPTIC TECHNIQUE, BRISK BLOOD RETURNED, BIOPATCH APPLIED, NEEDLE SECURED WITH TEGADERM DRESSING. KVO ;D5 ;INITIATED VIA PAC AND PRE-MEDS ADMINISTERED. 20 MINS INTO ZOFRAN/DECADRON INFUSION, PATIENT STARTED COMPLAIN OF DISCOMFORT AT THE PORT SITE. MODERATE SWELLING NOTED AROUND THE PORT SITE. INFUSION STOPPED. DRESSING REMOVED AND PORT DEACCESSED. SMALL AMOUNT OF CLEAR, BLOOD-TINGED FLUID EXPRESSED FROM THE SITE. SWELLING SLIGHTLY IMPROVED. PORT REACCESSED USING STERILE TECHNIQUE BY RN. PATIENT COMPLAIN OF PAIN WHEN TRYING TO FLUSH WITH 10CC NS SYRINGE, MINIMAL AMOUNT OF BLOOD RETURN NOTED (<1 ML). PORT COVERED WITH TEGADERM AND PROVIDER NOTIFIED BY NURSE. PATIENT SENT TO IR FOR PORT STUDY. CHEMOTHERAPY MEDICATIONS RETURNED TO PHARMACY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
222414 SMART PORT CT PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. CT80STPD 5772390

Patients

Seq Age Sex Outcome Treatment
1 21900 DA Male