MalfunctionLIO
BD AFFIRM VPIII AMBIENT TEMPERATORU TRANSPORT SYSTEM
Received Jan 28, 2021 · Event occurred Jan 26, 2021
Report MW5099090 · MDR key 11250990
Device
Generic name
Device, Specimen Collection
Manufacturer
Becton Dickinson And CompanyModel number
L001317(05)Lot number
B03C057M
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Description of Event or Problem
STAFF WAS USING THE AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM AND WHEN THEY WERE ATTEMPTING TO BREAK THE AMPULE TO RELEASE THE MEDIA INTO THE SPECIMEN CUP THEN A SHARD OF GLASS PUNCTURED THE STAFF MEMBER'S FINGER THROUGH THE SIDE OF THE AMPULE. FDA SAFETY REPORT ID#: (B)(4).