MalfunctionNZP

HALYARD

Received Jul 22, 2021 · Event occurred May 27, 2021

Report 12210746 · MDR key 12210746

Device

Generic name

Sealant, Microbial

Manufacturer

Avanos Medical, Inc.

Model number

33737

Catalog number

33737-01

Product problems

Leak/Splash
Unsealed Device Packaging

Patient

Not reported

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

STAFF ARE RECEIVING PACKAGES WHERE THE SEAL ON THE APPLICATOR IS BROKEN WITHIN THE PACKAGE AND LEAKS OUT/CONTAMINATED OR THE SEAL WON'T BREAK IN ORDER TO DISPENSE/RELEASE THE SEALANT. DEFECTIVE SAMPLES AND PACKAGING NOT SAVED. REQUESTED STAFF TO SAVE IN THE FUTURE FOR REPORTING AND TRACKING.