The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
|
The customer reported that a nasogastric tube ruptured resulting in a patient aspirating.The nasogastric tube involved in the incident was from another manufacturer (avanos - 10fr fine bore nasogastric corpak pur feeding tube).The syringe used to flush the blocked tube was a cardinal health 6ml enfit syringe.It was reported that there were several factors involved in this incident and the customer is unable to identify exactly what caused the rupture; the tube had been in place for 6 weeks, the patient had a gastroscopy procedure while the tube remained in place, and post procedure the tube became blocked so the nurse flushed the tube with coke using the cardinal health enfit 6ml syringe to unblock the tube.The feeding was recommenced and subsequently the patient aspirated.When this was identified, the feeding was ceased and the tube was removed, which was when the rupture was discovered.The patient was a critically unwell patient and passed away 12 days later.The customer reported that it is not believed that this incident caused the death but may have contributed to the patient¿s further deterioration.It was reported that the other manufacturer's (avanos) instruction for use (ifu) states that excessive syringe pressure should be avoided.
|