inforMED
MalfunctionOVN

CARDINAL HEALTH

Received Jun 17, 2025 · Event occurred Apr 25, 2025

Report 22231208 · MDR key 22231208

Device

Generic name

Suture Kit

Model number

ACS-SLAC4A

Catalog number

ACS-SLAC4A

Lot number

411974

Product problems

  • Use of Device Problem
  • Defective Device

Patient

12 MO · Male

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

PATIENT ARRIVED AT [TIME REDACTED] WITH FINGER LACERATION AFTER CLIMBING OUT OF HIS CRIB. PROVIDER IN TO SUTURE WOUND AND FAULTY EQUIPMENT IN ER LACERATION TRAY CUT THREAD. PROVIDER HAD TO OPEN THE PLASTICS TRAY TO HAVE TOOLS TO REPAIR LACERATION ON CHILD. MANUFACTURER RESPONSE FOR SUTURE KIT, CARDINAL HEALTH (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.