MalfunctionOJV

PRESOURCE LACERATION TRAY

Received Sep 15, 2025 · Event occurred Sep 8, 2025

Report MW5176071 · MDR key 23053734

Device

Generic name

Single Use Instrument Tray

Manufacturer

Cardinal Health 200, Llc

Catalog number

05A0177B

Lot number

555407

Product problems

Material Separation

Patient

6 YR · Female

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

Narrative

Description of Event or Problem

WHILE OMFS RESIDENT WAS FINISHING REPAIRING A LACERATION INSIDE THE PATIENT'S CHEEK, THE NEEDLE HOLDER FELL APART. THE PATIENT WAS NOT OTHERWISE INJURED FROM THE PRODUCT DEFECT.