MalfunctionJSG
BUFFERED SALINE SOLUTION 0.85%
Received Jan 7, 2022 · Event occurred Jan 4, 2022
Report MW5106523 · MDR key 13205482
Device
Generic name
Culture Media, Non-selective And Non-differential
Manufacturer
Azer Scientific Inc.Model number
ES45044Lot number
26858
Product problems
- Fluid/Blood Leak
- Connection Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
[STERILE BUFFERED SALINE SPECIMEN CONTAINER] USE FOR COVID-19 UNDER EMERGENCY USE AUTHORIZATION (EUA): THE CONTAINERS WITH THE STERILE BUFFERED SALINE IN IT WAS FOUND WITH THE CAP NOT ON COMPLETELY AND THE SALINE SOLUTION HAD LEAKED OUT OF THE CONTAINER. FDA SAFETY REPORT ID# (B)(4).