FDA Adverse Event Injury Summary report: N

PLEURX PLEURAL CATHETER KIT

MDR report key: 14309487 · Received May 6, 2022

Report

Report Number
14309487
Event Type
Injury
Date Received
May 6, 2022
Date of Event
April 22, 2022
Report Date
April 18, 2022
Manufacturer
CAREFUSION 2200, INC
Product Code
DWM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

ATTEMPTING TO DE-CLOG PATIENT'S EXISTING PLEURX CATHETER BY FLUSHING WITH STERILE WATER THROUGH A CONNECTED PLEURX LOCKABLE DRAINAGE LINE AND THE CONNECTOR ON THE PLEURX CATHETER POPPED OFF DURING FLUSH. SLIDE CLAMP FROM LOCKABLE DRAINAGE LINE KIT IMMEDIATELY APPLIED. THORACENTESIS THEN PERFORMED FOR PATIENT TO DRAIN PLEURAL EFFUSION AND PLEURX CATHETER WAS REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
976180 PLEURX PLEURAL CATHETER KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION 2200, INC 50-7000B 0001441804

Patients

Seq Age Sex Outcome Treatment
1 Unknown Required Intervention