MalfunctionQMC

STERILE SALINE 0.85%

Received Nov 1, 2023 · Event occurred Sep 26, 2023

Report MW5147678 · MDR key 18060340

Device

Generic name

Transport Medium, Notified Per The Vtm Guidance

Manufacturer

Edge Biologicals Inc.

Lot number

01223

Patient

Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

STERILE SALINE ORDERED FOR TESTING. BOX LABELED 0.85% STERILE SALINE, TUBES INSIDE WERE LABELED STERILE WATER. SAMPLES ON 40+ VETERANS AND EMPLOYEES NEEDED TO BE RECOLLECTED DUE TO IMPROPER TRANSPORT MEDIA. THE MANUFACTURER IS EDGE BIOLOGICALS INC. (598 N. 2ND ST, MEMPHIS TN 38105) WWW.EDGEBIOLOGICALS.COM LOT 01223, EXP 01/23/2024.