Model Number 765100 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 the end user reported over the past few months the feeding sets are coming apart where the tube meets the connector causing the formula to leak.There was no patient harm.
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Manufacturer Narrative
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Eight used samples were received for evaluation.Visual and functional inspection was performed and found 3 cross spikes detached from the line, the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.
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Search Alerts/Recalls
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