MalfunctionNNI

CONTAINER, SPECIMEN, NON-STERILE

Received Oct 8, 2020 · Event occurred Mar 27, 2020

Report 10648073 · MDR key 10648073

Device

Generic name

Container, Specimen, Non-sterile

Manufacturer

Medegen Medical Products

Catalog number

03341-9

Product problems

Crack
Leak/Splash

Patient

Not reported

Chemical Exposure
Chemical Exposure

Narrative

Description of Event or Problem

CUPS ARE CRACKING. PRIMARILY ON THE BOTTOM AND OCCASIONALLY ON THE SIDES. SAMPLES ARE BEING RE-COLLECTED UNNECESSARILY AND ASSOCIATES ARE EXPOSED TO BIOHAZARD FROM LEAKAGE. MANUFACTURER DATES OF 11/5/2019 AND 2/10/2020.