Model Number 763656 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
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Event Description
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The customer reported the feeding set was leaking from the spike connection.The feed was found dripping on the floor.
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Manufacturer Narrative
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H 3 evaluation summary no device history record (dhr) review could be performed because the lot number is unavailable.One used sample was received for evaluation.Visual and functional evaluation was performed, and the device was found to have a detached line from the cross spike.A photograph was also provided showing the detachment of the cross-spike connector.Root cause and action plan will be documented through a formal corrective and preventative action (capa).This complaint will be closed with no further action and will be used for tracking and trending purposes.
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Search Alerts/Recalls
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