[18331662]
Laryngectomy tube malfunctioned, causing a breathing problem. Pt's husband provided the following info regarding an incident experienced by his wife. Following a tracheotomy procedure on or about 7/20/98, the physician inserted a portex laryngectomy tube mfg by sims in keene, nh. The device consists of a polyvinyl chloride tube with a disposable inner cannula, which is a plastic component having a "pull ring" for inserting or removing the inner cannula from the tube. The inner cannula functions to prevent materials from back flowing into the airway and needs to be cleaned periodically in order to assure there are no obstructions in the airway. Pt's husband said his wife routinely removed the inner cannula at least daily in order to clean it. On 9/22/98, when pt attempted to remove the inner cannula, the plastic "pull ring" broke, and the body of the inner cannula remained in the tube. She was having difficulty breathing and pt's husband had to use pliers to remove the inner cannula, and restore normal breathing to his wife. Medical attention was not obtained. Pt's husband telephoned sims and spoke with an unidentified female. He was told, the product insert states the device should be changed every 29 days and the inner cannula needs to be replaced as needed. Pt's husband said the physician never provided them with these instructions verbally. The insert states the inner cannula needs to be visually checked. Sims intends to send the pt a case of inner cannulas at no charge. The sims rep never requested to see the malfunctioned device, nor did they inquire as to the lot number. Pt's husband said about 30 days ago, the inner cannula developed a crack in the body and was replaced with the current inner cannula which also became defective. He has both defective inner cannula's in his possession and will hold them in the event fda wishes to examine the defects.
Patient Sequence No: 1, Text Type: D, B5