inforMED
MalfunctionFSH

N/A

Received Jun 2, 2025 · Event occurred May 20, 2025

Report 22122550 · MDR key 22122550

Device

Generic name

Tray, Surgical, Needle

Model number

4382SP

Catalog number

4382SP

Lot number

REJ20950

Product problems

  • Contamination

Patient

73 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

FROM STAFF: DR. POINTED OUT SOME FOREIGN MATERIAL IN A STERILE BIOPSY TRAY, LOOKED LIKE SOMETHING ORGANIC INITIALLY THOUGHT TO BE A PIECE OF DRY GRASS, THIS WAS REFOLDED AND REMOVED TO NURSING MANAGER'S OFFICE. ON ASSESSMENT AFTERWARD NURSING MANAGER PALPATED DEBRIS AND DESCRIBES IT AS " HARD, LIKE CARDBOARD" A NEW TRAY WAS USED FOR THE PROCEDURE.