inforMED
MalfunctionOVN

CARDINAL HEALTH

Received Apr 18, 2025 · Event occurred Apr 12, 2025

Report 21864601 · MDR key 21864601

Device

Generic name

Suture Kit

Model number

ACS-S-LAC4

Catalog number

ACS-S-LAC4

Lot number

404310

Product problems

  • Product Quality Problem
  • Failure to Cut

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ANOTHER FAILURE. ED [EMERGENCY DEPARTMENT] PROVIDERS REPORT THAT THE SCISSORS IN THIS KIT DO NOT CUT 60% OF THE TIME, PICK-UPS FAIL ~ 30% OF THE TIME, AND NEEDLE DRIVER FAILS ~70% OF TIME AND OFTEN CUT SUTURE MATERIALS. MANUFACTURER RESPONSE FOR SUTURE KIT, CARDINAL HEALTH (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.