inforMED
MalfunctionFOD

DEROYAL

Received Oct 27, 1999

Report 1055236-1999-00010 · MDR key 247839

Device

Generic name

Umbilical Cord Clamp

Model number

NA

Catalog number

6833-B

Lot number

57062

Product problems

  • Disengaged
  • Replace
  • Locking mechanism failure

Patient

*

  • Bleeding
  • Blood Loss

Narrative

Description of Event or Problem

AFTER APPLICATION OF UMBILICAL CORD CLAMP, THE LATCH POPPED OPEN WHILE THE INFANT WAS STILL IN OBSERVATION IN LABOR AND DELIVERY. MINIMAL BLOOD LOSS OCCURRED. A NEW CORD CLAMP WAS APPLIED, AND NO ADDITIONAL TREATMENT WAS NECESSARY.