Catalog Number 670175 |
Device Problems
Material Discolored (1170); Fluid/Blood Leak (1250); Cut In Material (2454)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/24/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Potential lot numbers - 3117359 and 3129407, additional 510(k) - k083641.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that the cuff of a portex® bivona® adult tts¿ tracheostomy tube leaked after 20 days in use.Cuff patency had been tested prior to use.The tracheostomy tube had been reprocessed twice with boiled water prior to the event.Sterile water was used to fill the cuff.Hospital personnel noticed the issue after the ventilator alarmed.Once the leak was found, the tracheostomy tube was replaced.No injury was reported, however, the outcome of the event was reported to be ongoing.
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Manufacturer Narrative
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Smiths medical received one 7.5 mm portex® bivona® adult tts¿ tracheostomy tube for analysis.Discoloration of the tracheostomy (trach) tube was noted upon visual inspection.Inflation test was performed using a standard syringe; 16 cc of air was inserted into the inflation line with no noted cuff inflation.A leak coming from the cuff was observed while performing a system leak test.A cut, 1 mm in length, was noted in the cuff at that time.Instructions for use reviewed which states not to come into contact with sharp objects.Manufacturing procedures reviewed which reflects that quality performs a sample leak test on the devices prior to packaging.Based on the evidence, the investigation did not determine a manufacturing defect.No corrective actions are required at this time.
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Search Alerts/Recalls
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