inforMED
MalfunctionLRO

MAJOR GENERAL PACK SJMC

Received May 6, 2026

Report MW5187780 · MDR key 25095387

Device

Generic name

General Surgery Tray

Model number

SBA11MPX17

Lot number

704276

Product problems

  • Delivered as Unsterile Product
  • Device Contaminated During Manufacture or Shipping

Patient

44 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

STERILE BACK TABLE PACK OPENED, SMALL PIECE OF CARDBOARD IN THE PACK. SET UP THROWN AWAY. SECOND PACK OPENED AND ANOTHER SMALL PIECE OF CARDBOARD WAS PRESENT WITHIN THE PACK. THIRD PACK OPENED AND EXAMINED, NO CARDBOARD PRESENT. LOT NUMBER WAS THE SAME FOR BOTH PACKS. DEVICE: 1421; 2969. PATIENT: 4582. REFERENCE: MW5187781.