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Model Number 775659 |
Device Problems
Detachment Of Device Component (1104); Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/15/2018 |
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported that the tubing of the feeding set disconnected from the anti-reflux valve after loading prior to priming and leaked formula.There was no patient involvement.
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Manufacturer Narrative
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A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.One used sample was received for evaluation.The sample was visually evaluated.The sample was found to be clogged with dry formula along the pvc lines that obstructed the tube path at the valve level, no functional evaluation could be performed since the product could not be unclogged.No fault was found related to manufacturing.No corrective actions will apply since failure mode was not confirmed related to manufacturing, it will be confirmed as unknown source.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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