inforMED
DeathKYZ

IRRIGATION TRAY

Received Oct 10, 2024 · Event occurred Dec 8, 2023

Report MW5160967 · MDR key 20429360

Device

Generic name

Syringe, Irrigating (non Dental)

Model number

6820

Catalog number

KE68820

Lot number

2312920864

Patient

45 YR · Female

  • Fever
  • Unspecified Infection
  • Fever
  • Unspecified Infection

Narrative

Description of Event or Problem

PATIENT HAD CANCER, AND WAS USING A URINARY CATHETER, THAT REQUIRED THE USE STERILE SALINE AND PRODUCTS ASSOCIATED WITH NURSE ASSIST TRAY. ON (B)(6) 2023 MY WIFE'S AT HOME NURSE REPLACED HER CATHETER USING ONE OF THE NURSE ASSIST TRAYS THAT TURN OUT TO BE PART OF A PRODUCT RECALL. THE NEXT DAY MY WIRE HAD A FEVER AND SHE HAD TO BE HOSPITALIZE. SHE WAS DIAGNOSE WITH AND INFECTION CAUSE BY CONTAMINATION FROM THE NURSE ASSIST KIT. WE DID NOT RECEIVE A LETTER ABOUT THE RECALL UNTIL (B)(6) OF 2014, AND MY WIFE DIED ON (B)(6) 2024.