inforMED
MalfunctionKDW

ENDOCATCH BAG

Received Feb 3, 2023 · Event occurred Jan 18, 2023

Report MW5114689 · MDR key 16304629

Device

Generic name

Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Model number

FEP936116B

Lot number

6252106192

Product problems

  • Material Rupture

Patient

63 YR · Female

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

Narrative

Description of Event or Problem

ENDO CATCH BAG BROKE UPON PULLING SPECIMEN OUT OF BODY.