inforMED
MalfunctionOVN

CARDINAL HEALTH

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

Report 21864627 · MDR key 21864627

Device

Generic name

Suture Kit

Model number

ACS-S-LAC4

Catalog number

ACS-S-LAC4

Lot number

343915

Product problems

  • Mechanical Problem
  • Failure to Cut
  • Defective Device

Patient

9 YR · Male

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

Narrative

Description of Event or Problem

ED 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. USER FACILITY MOVED TO NON-DISPOSABLE TRAYS WITH ON-GOING FAILURES OF CURRENT KITS. MANUFACTURER RESPONSE FOR SUTURE KIT, CARDINAL HEALTH (PER SITE REPORTER): WAITING FOR THEIR RESPONSE.