A customer reported via medwatch report number (b)(4) that a pediatric patient was intubated in the emergency room for airway protection and prior to transport departure to another facility.After the endotracheal tube (ett) was secured by the physician, the cuff was inflated and the stylet was to be removed.During the stylet removal, the stylet broke inside the ett and they were unable to remove it on the first attempt.As the ett was occluded with the broken stylet, the patient was immediately bagged by respiratory.The patient's oxygen saturation (sats) returned to 100% before the doctor manually attempted to remove the rest of the broken stylet which was eventually successfully removed.Upon being notified about the incident by the facility, it was reported to verathon that the stylet broke off below the stopper in the ett upon removal.The physician used a hemostat to successfully remove the broken piece from the ett.No harm to the patient was reported.
|
The customer was unable to have the gliderite single-use stylet - small returned to verathon for evaluation as it was thrown away at their facility.Since the device was not returned to verathon for evaluation, the cause could not be determined.Verathon attempted to follow-up with the facility for additional information regarding the reported event and use of the device, including the model and size of the ett used with the stylet.To date, no response has been received.Trending analysis for the gliderite single-use stylets does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.
|