MalfunctionOJV

LACERATION TRAY

Received Sep 17, 2025 · Event occurred Sep 13, 2025

Report MW5176207 · MDR key 23077475

Device

Generic name

Single Use Instrument Tray Kit

Manufacturer

Cardinal Health 200, Llc

Model number

STK2UPRED

Catalog number

HT06-8400

Lot number

526054

Product problems

Difficult to Open or Close

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WHILE USING THE CARDINAL HEALTH LACERATION TRAY COMBAT APPLICATION TOURNIQUET (CAT) HT06-8400, THE FORCEPS HOLDER WOULD NOT HOLD A NEEDLE SECURELY. THE FORCEP HOLDERS WOULD OPEN UP WHEN ATTEMPTING TO SUTURE A LACERATION IN THE EMERGENCY DEPARTMENT. THE PHYSICIAN STATES ANOTHER DAY HE WAS UNABLE TO GET FORCEP HOLDERS TO OPEN.