MalfunctionCCI

86-000790 ANESTHESIA KIT-BELLIN MEMORIAL

Received Feb 25, 2000 · Event occurred Jan 27, 2000

Report 1055236-2000-00003 · MDR key 266274

Device

Generic name

7f1 Anesthesia Kits

Manufacturer

Deroyal

Model number

Catalog number

KIT # 86-000790

Lot number

63969

Product problems

Air Leak
Leak/Splash

Patient

UNKNOWN

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

CONTAINED IN THE ANESTHESIA KIT IS A Y-ELBOW PART THAT CONNECTS THE TUBING AND THE MASK TOGETHER. THE VERY BEGINNING OF A SURGICAL PROCEDURE, THE Y-ELBOW THAT CONNECTS TO THE MASK LEAKED WHEN UNDER PRESSURE. NO PT INJURY OCCURRED.

Remedial action

Other