inforMED
MalfunctionFHO

INSUFFLATION NEEDLE 120MM

Received Sep 10, 2021 · Event occurred Apr 22, 2021

Report MW5103860 · MDR key 12460518

Device

Generic name

Pneumoperitoneum Needle

Manufacturer

Covidien

Model number

TOL028X

Product problems

  • Use of Device Problem
  • Infusion or Flow Problem

Patient

24 YR

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE NEEDLE WAS INSERTED IN TO THE PATIENT'S ABDOMEN AND WAS UNABLE TO INSUFFLATE, THE NEEDLE WAS REMOVED AND A DIFFERENT NEEDLE WAS INSERTED WITHOUT INCIDENT. FDA SAFETY REPORT ID # (B)(4).