inforMED
MalfunctionFSQ

SATIN SLIP

Received Sep 29, 2004

Report 2936999-2004-00033 · MDR key 5317948

Device

Generic name

Intubation Stylet Sterile

Manufacturer

Respiratory

Catalog number

85863

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Choking

Narrative

Additional Manufacturer Narrative

THE HOSPITAL HAS NOT RETURNED THIS DEVICE TO NELLCOR AND THEREFORE EVAL IS NOT POSSIBLE AT THIS TIME. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL OR CORRECTED REPORT WILL BE PROVIDED TO THE FDA FOLLOWING COMPLETION OF THE EVAL.

Description of Event or Problem

DURING A DIAPER CHANGE, THE INFANT COUGHED AND THE ATTENDING RN NOTED SMALL TUBE IN PATIENT'S THROAT. TUBE REMOVED BY OTOLARYNGOLOGIST. PATIENT HAS SINCE BEEN DISCHARGED FROM HOSPITAL.