MalfunctionFEF

SENGSTAKEN TUBES

Received Sep 15, 1998 · Event occurred Aug 29, 1998

Report 8010092-1998-00057 · MDR key 188395

Device

Generic name

Ultra Blakemore Tube - 3 Lumen

Manufacturer

Rusch Mfg. Uk, Ltd.

Model number

Catalog number

2300-21

Lot number

E343601

Product problems

Balloon rupture
Balloon burst

Patient

UNKNOWN

No Consequences Or Impact To Patient
Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

PT WAS ADMITTED WITH BLEEDING IN THE ESOPHAGUS. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO USE THREE BLAKEMORE TUBES UNSUCCESSFULLY. THE BALLOONS ON ALL THREE DEVICES POPPED.