FDA Adverse Event Malfunction Summary report: N

PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)

MDR report key: 19358310 · Received May 21, 2024

Report

Report Number
19358310
Event Type
Malfunction
Date Received
May 21, 2024
Date of Event
February 28, 2024
Report Date
March 5, 2024
Manufacturer
MEDICAL COMPONENTS, INC.
Product Code
LJS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT¿S MOTHER (MOP) CONTACTED OPE ABOUT A LINE PLACED FOR PATIENT THAT LEAKED, SO PATIENT WAS IN SURGERY IN THE MORNING OF [DATE REDACTED] TO REPLACE IT. IT IS MOP¿S ASSERTION THAT THE LINE WAS DEFECTIVE. PATIENT'S LINE WAS PLACED ON [DATE REDACTED]. PATIENT'S LINE LEAKED AFTER TWO MONTHS AND WAS NOT FIXED BY A NEW CAP OR THE VASCULAR TEAM'S ASSISTANCE. MOP HAS NO COMPLAINTS AGAINST DOCTORS OR NURSES, BUT STATES THERE WAS HARM TO PATIENT HAVING TO GO THROUGH ANOTHER PROCEDURE TO REPAIR THE PROBLEM WITH THE LINE ON THE MORNING OF [DATE REDACTED]. MOP¿S QUESTIONS AND REQUESTS: WANTS TO KNOW IF THE FAULTY LINE PLACED IN PATIENT IS A NEW PRODUCT. SHE WANTS TO KNOW IF IT WAS TESTED WELL, AND IF THERE WERE KNOWN ISSUES WITH THIS PRODUCT BEFORE USING IT ON PATIENTS. WANTS SOMEONE TO LOOK INTO WHAT HAPPENED WITH PATIENT SO OTHER USERS OF THIS LINE ARE AWARE OF THIS DEFECT. MOP STATES THAT OTHER DOCTORS AND HOSPITALS NEED TO KNOW ABOUT THIS. WANTS A RESPONSE ABOUT WHAT IS FOUND BY AN INVESTIGATION AND WHAT IS BEING DONE ABOUT IT. PER MOP: PATIENT¿S LINE WAS PLACED ON [DATE REDACTED]. ON [DATE REDACTED], MOP LEARNED THAT THE LINE WAS BROKEN. MOP SAID, ¿IT IS A FAULTY PRODUCT¿ AND WANTS TO KNOW WHAT THE HOSPITAL DOES TO REPORT THIS SO IT WILL NOT HAPPEN TO ANY OTHER PATIENT HERE OR IN OTHER HOSPITALS. MOP EXPLAINED THAT WHILE THE STAFF WAS FLUSHING THE LINE ON [DATE REDACTED], IT WAS DRIPPING, SO THEY CHANGED THE CAP. ¿THE VASCULAR TEAM ALSO CAME IN AND CREWED THE SYRINGE DIRECTLY TO THE LINE, BUT IT WAS STILL DRIPPING WHEN THEY PUSHED ON IT.¿ MOP LEARNED THAT THE ONLY WAY TO FIX THE LEAKY LINE WAS TO REPLACE IT, SO PATIENT IS IN THE TREATMENT CENTER THIS MORNING TO REPLACE THE LINE. MOP THINKS THERE IS HARM TO PATIENT TO HAVE TO GO THROUGH THE PROCEDURE TODAY BECAUSE OF A FAULTY PRODUCT. MOP ADDS THAT IT ALSO MEANS LONGER ADMISSION FOR PT. MOP HOPES PATIENT DOES NOT GET AN INFECTION FROM THE ADDED PROCEDURE TODAY. THE PRIOR LINE THAT WAS PLACED BY LPCH TO THIS LINE LASTED FOR TWO YEARS. MOP ALSO SHARED PICTURES OF THE CARD GIVEN TO HER WHEN THE LINE WAS INITIALLY PLACED ON [DATE REDACTED]. THE CARD SHOWS: MEDCOMP, PRO-PICC CT, PRO-LINE CT, REF: MD28037201, 7F X 60CM DL PRO-LINE CT, LOT MQZA580, USE BY 10-17-2026.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1617868 PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST) CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS, INC. MD28037201 MQZA580

Patients

Seq Age Sex Outcome Treatment
1 8 YR Female