inforMED
MalfunctionFHO

PNEUMO-MATIC INSUFFLATION NEEDLE

Received Dec 4, 2017 · Event occurred Dec 1, 2017

Report MW5073738 · MDR key 7083362

Device

Generic name

Verres Needle

Manufacturer

Cooper Surgical

Model number

900-100

Catalog number

900-100

Lot number

225665

Product problems

  • Leak/Splash
  • Device Operates Differently Than Expected

Patient

Not reported

  • No Information
  • No Information

Narrative

Description of Event or Problem

COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLES, 14 GAUGE, 150 MM, X WOULD NOT PASS LEAK TEST. THE 900-210 FROM LOT # 186236 - EXP DATE: 11/2018. THE 900-200 FROM LOT # 225665 - EXP. DATE 07/11/2020.