MalfunctionLWH

MEDLINE

Received Sep 9, 2021 · Event occurred Apr 19, 2021

Report 12445773 · MDR key 12445773

Device

Generic name

Counter, Sponge, Surgical

Manufacturer

Medline Industries, Inc.

Model number

DYNJE1001

Catalog number

DYNJE1001

Lot number

68020080002

Product problems

Unsealed Device Packaging
Device Fell

Patient

Not reported

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

MEDLINE SPONGE COUNTER - POCKET ON 3RD ROW OF SPONGE COUNTER NOT SEALED - SPONGES FALL THROUGH. UNABLE TO USE FOR ACCURATE SPONGE COUNTING. REF: DYNJE1001. LOT #: 68020080002.