Catalog Number 1040 |
Device Problem
Disconnection (1171)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported that the oxygen tube easily disconnected from the mask before use.Therefore, a new unit was used instead.No patient involvement.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.During the visual exam it was observed that the female adaptor is easily disconnected from the grommet.The female adaptor tubing was found to be within dimensional specification.Based on the investigation performed, the reported complaint is confirmed.A capa was opened to address this issue.
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Event Description
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It was reported that the oxygen tube easily disconnected from the mask before use.Therefore, a new unit was used instead.No patient involvement.
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Search Alerts/Recalls
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