Adverse Reactions - Covidien Shiley Instrucciones De Uso

Note: The performance information shown on page 71 was collected using a Rigid Cylinder Trachea Model bench
test that is intended to provide a comparison of the sealing characteristics of tracheal tube cuffs only in a laboratory
setting and is not configured or intended to predict performance in the clinical setting.

ADVERSE REACTIONS

The following adverse reactions have been reported to be associated with the use of cuffed tracheal tubes during the
intubation procedure, during the intubation period, or subsequent to extubation. The order of listing is alphabetical
and does not indicate frequency or severity.
Reported adverse reactions* include: abrasion of the arytenoid cartilage vocal process; cartilage necrosis; cicatrix
formation; consequences of failure to ventilate including death; damage to the perichondrium; development of
dense or diffuse fibrosis invading the entire glottic area; emphysema; endobronchial aspiration; endobronchial
intubation (hypoxemia); endotracheobronchial aspiration; epistaxis; esophageal intubation (stomach distention);
excoriated membranes of the pharynx; eye trauma; fibrin deposition; formation of subglottic web; fracture-luxation
of cervical column (spinal injury); fragmentation of cartilage; glottic edema (supraglottic, subglottic, retroarytenoidal);
granuloma of the inner arytenoid area; infections (laryngitis, sinusitis, abscess, respiratory tract infection);
inflammation; intermittent aphonia and recurrent sore throat; laryngeal fibrosis; laryngeal granulomas and polyps;
laryngeal obstruction; laryngeal stenosis; laryngeal ulcers; laryngotracheal membranes and webs; membraneous
glottic congestion; membraneous tracheobronchitis; mild edema of the epiglottis; mucosal changes; mucosal
sloughing; paresis of the hypoglossal and/or lingual nerves; perforation of esophagus; perforation of the trachea;
pneumothorax; replacement of the tracheal wall with scar tissue; respiratory obstruction; retrobulbar hemorrhage;
retropharyngeal abscess; retropharyngeal dissection, rupture of the trachea; sore throat, dysphagia; stricture of nostril;
stridor; subglottic annular cicatricial stenosis; submucosal hemorrhage, submucous puncture of the larynx; superficial
epithelial abrasion; swallowed tube; synechia of the vocal cords; teeth trauma; tissue burns; tracheal bleeding; tracheal
stenosis; trauma to lips, tongue, pharynx, nose, trachea, glottis, palate, tonsil, etc.; traumatic lesions of the larynx and
trachea; ulcerations exposing cartilaginous rings and minor erosions at cuff site; ulceration of the lips, mouth, pharynx,
ulcers of the arytenoid; vocal cord congestion; vocal cord paralysis, and vocal code ulcerations.
*Helpful references for more detailed discussions of tracheal tube adverse reactions include the following:
1. Baron, S.H., and Kohlmoos, H.W.: Laryngeal sequelae of endotracheal anesthesia.
Ann. Otol. 60:767-792, 1951.
2. Blanc, V.F., and Tremblay, N.A.G.: The complications of trachea following intubation.
Anesth. Analg. 53:202-213, 1974.
3. Campbell. D.: Trauma to larynx and trachea following intubation and tracheostromy.
J. Laryng. 82-981-986, 1968.
4. Cooper, J.D., and Grillo, H.C.: The evolution of tracheal injury due to ventilatory assistance through cuffed tubes.
Ann. Surg. 169:334-348, 1969.
5. Gross, C.W., and Gros, J.C.: Rare complications after prolonged translaryngotracheal intubation.
Ann. Otol. 80:582-584, 1971.
6. McGovern, F.H., Fitz-Hugh, G.S., and Edgemon, L.J.: The hazards of endotracheal intubation.
Ann. Otol. 80-556-564, 1971.
SUGGESTED DIRECTIONS FOR USE
1. Remove the sterile RAE Tracheal Tube with TaperGuard cuff from its protective package and perform the
following inspections:
A. Test the cuff, pilot balloon and valve of each tube by inflation prior to use. Insert a luer tip syringe into the
cuff inflation valve housing and inject enough air to fully inflate cuff. After test inflation of the cuff, completely
evacuate the air.
B. Carefully inspect the tube and 15 mm connector prior to use. If the 15 mm connector is not seated at all or is
loose in the package, do not use.
2. After orienting the 15 mm connector position, firmly seat it as completely as possible.
3. Verify the security of this connection before intubation. If the 15 mm connector can be pulled out easily, use a
new tracheal tube and repeat the procedure.
4. Intubate the patient following currently accepted medical techniques with consideration given to the specific
cuff-related WARNINGS and CAUTIONS stated in this product insert. Follow currently accepted medical
techniques to ensure that the endotracheal tube has been placed into the trachea, and not inadvertently
placed into the esophagus or a mainstem bronchus.
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