inforMED
MalfunctionFOD

UMBILI-KIT

Received Aug 8, 2022 · Event occurred Jun 21, 2022

Report 15182541 · MDR key 15182541

Device

Generic name

Device, Occlusion, Umbilical

Catalog number

CLW-1001-A01

Lot number

20200620

Product problems

  • Detachment of Device or Device Component

Patient

Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

WITHIN 30 MINUTES OF PLACING UMBILICAL CORD CLAMP, THE MOTHER CALLED FOR ASSISTANCE TO RECLAMP THE CORD. THE CLAMP WAS NO LONGER ON THE UMBILICAL CORD. MOTHER HELD PRESSURE W/ FINGERS UNTIL NURSING ARRIVED IN ROOM.