inforMED
MalfunctionGJE

MONOJECT

Received Nov 13, 2013 · Event occurred Nov 6, 2013

Report 3560680 · MDR key 3560680

Device

Generic name

Set, Blood Collection

Manufacturer

Covidien

Model number

*

Catalog number

8881225307

Lot number

131150160X

Product problems

  • Leak/Splash
  • Defective Device

Patient

*

  • No Information

Narrative

Description of Event or Problem

WHILE DRAWING BLOOD, THE BLOOD LEAKED FROM THE PROXIMAL END OF THE VENIPUNCTURE TUBING AND LEAKED ONTO THE PATIENT'S CLOTHING. THE TUBING WAS DEFECTIVE AND HAD A LEAK.