IRRIGATION TRAY
Received Oct 10, 2024 · Event occurred Dec 8, 2023
Report MW5160967 · MDR key 20429360
Device
Generic name
Syringe, Irrigating (non Dental)
Manufacturer
Cardinal Health (kenmex Medical Specialties)Model number
6820Catalog 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.