Catalog Number 100/860/090 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2020 |
Event Type
malfunction
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Event Description
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Information was received indicating that during use of a smiths medical tracheostomy|pvc - portex tube blue line ultra (blu), it was noted that the customer noticed the suction line got detached.No patient consequences were reported.No adverse effects were reported.
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Manufacturer Narrative
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Device evaluation results: one portex tracheostomy tube was returned for investigation used condition.The returned sample was visually inspected at 12 to 16 inches and under normal conditions of illumination.The suction line was detached.The customer reported product problem was therefore confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.
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Manufacturer Narrative
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Other, other text: h10 ? device evaluation results: one portex tracheostomy tube was returned for investigation used condition.The returned sample was visually inspected at 12 to 16 inches and under normal conditions of illumination.The suction line was detached.The customer reported product problem was therefore confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.
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Search Alerts/Recalls
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