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Model Number 775100 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2019 |
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that the device leaked nutrition at the puncture site of the nutrition bag.
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Manufacturer Narrative
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The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used sample was received for the evaluation.Upon visual and formal inspection, the reported condition is confirmed.A corrective and preventive action (capa) has been opened.The root cause and the action plan will be documented through formal investigation.
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Search Alerts/Recalls
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