inforMED
MalfunctionPEZ

MEDICAL ACTION INDUSTRIES

Received Sep 11, 2019 · Event occurred Aug 14, 2019

Report 8990725 · MDR key 8990725

Device

Generic name

Central Venous Catheter Dressing Change Kit

Model number

77433

Catalog number

77433

Lot number

260139

Product problems

  • Component Missing
  • Material Integrity Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

MEDICAL ACTION INDUSTRIES INC. CVC REDRESS KIT RED #77433, LOT#260139, EXP 01-31-2021. CVC REDRESS KIT DID NOT HAVE A BIOBATCH, STERILE GLOVES WERE ABNORMALLY THIN AND EASY TO RIP, AND CHLORA-PREP SWABS WERE DRY.