inforMED
MalfunctionFEF

RUSCH

Received Sep 17, 2001

Report 9610520-2001-00164 · MDR key 352298

Device

Generic name

Fr Sengstaken Blake Tube

Manufacturer

Rusch

Model number

NA

Catalog number

204860210

Lot number

UNK

Product problems

  • Tears, rips, holes in device, device material

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE CUSTOMER REPORTS THAT THE BLAKEMORE TUBE HAD A HOLE/SMALL TEAR IN THE GASTRIC BALLOON.