inforMED
MalfunctionOVN

CARDINAL HEALTH

Received Apr 18, 2025 · Event occurred Apr 13, 2025

Report 21864663 · MDR key 21864663

Device

Generic name

Suture Kit

Model number

ACS-S-LAC4

Catalog number

ACS-S-LAC4

Lot number

343915

Product problems

  • Defective Component

Patient

35 YR · Male

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

Narrative

Description of Event or Problem

SUTURE EQUIPMENT WAS NOT USABLE. HEALTHCARE PROVIDER HAD TO OBTAIN A SECOND KIT FOR USE ON PATIENT. SUTURE KITS HAVE HIGH FAILURE RATES FOR INDIVIDUAL COMPONENTS. FAILING AN AVERAGE OF 60% OF TIME FOR INDIVIDUAL COMPONENTS, SOME HIGHER. MANUFACTURER RESPONSE FOR SUTURE KIT, CARDINAL HEALTH (PER SITE REPORTER): WAITING FOR THEIR RESPONSE.