inforMED
MalfunctionFAX

BOUGIE

Received Jun 5, 2014 · Event occurred May 12, 2014

Report MW5036489 · MDR key 3866663

Device

Generic name

Introducer For Adult Endotracheal Intubation

Manufacturer

Sunmed

Model number

9-0212-70

Lot number

MD058

Product problems

  • Device Contamination with Chemical or Other Material

Patient

69 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

BOUGIE INTRODUCER TUBE USED FOR INTUBATION. AFTER WAS USED IN THE PATIENT'S MOUTH, APPROX AT THE 27 CM MARK THERE WAS A BROWN MARK THAT CORRESPONDING TO A BROWN MARK IN THE STERILE WRAPPER. THE TUBE WAS PLACED IN THE PATIENT'S MOUTH TO THE 23 CM MARK. NO PATIENT HARM DETECTED. DIAGNOSIS OR REASON FOR USE: ENDOTRACHEAL INTUBATION.