MalfunctionLIO
BD AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
Received May 6, 2021 · Event occurred May 5, 2021
Report MW5101235 · MDR key 11790133
Device
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
40 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THERE WAS A GLASS VIAL IN THE SPECIMEN CONTAINER RATHER THAN THE REAGENT DROPPER OF THE BD AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM KIT. FDA SAFETY REPORT ID# (B)(4).