Model Number 0046140 |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that the ng tube leaked from where it connects to the tubing.
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Event Description
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It was reported that the ng tube leaked from where it connects to the tubing.
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Manufacturer Narrative
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The device was not returned for evaluation.A potential failure mode could be ¿lopez valve not press-fit correctly into the tube¿ with a potential root cause of ¿lack of instructions to assembly operation¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "6.Do not inject fluid through the prevent filter as this may result in blockage and leakage of filter.".
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Search Alerts/Recalls
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