Catalog Number 100/810/085 |
Device Problem
Material Perforation (2205)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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® blue line ultra® tracheostomy tube "perforated".The cuff was "drilled into the patient".The fault was identified eight days after placement.It was noted that the patient was comfortable and "without respiratory effect".No injury was reported.
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Manufacturer Narrative
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One portex® blue line ultra® tracheostomy tube was received in used condition.The sample was visually inspected at a distance of 12 to 24 inches.No holes were detected.The cuff was inflated and submerged under water.A leak was found in the cuff.A review of the manufacturing and quality processes was conducted and was considered adequate and correct.Per previous complaints, retraining of the production personnel was conducted in order to reinforce the inflation test operation.Based on the evidence, the complaint was confirmed.The root cause is unknown.
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Search Alerts/Recalls
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