Model Number 8884721088E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pneumothorax (2012)
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Event Type
Injury
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Event Description
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The customer reported they had a placement with a 12fr/43in tube in the previous week that was confirmed with pneumothorax but no death or other harm occurred.They made the decision to pull the 12fr tubes from the floors thinking it could be a product issue.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
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Manufacturer Narrative
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Corrected section h1/h2 type of reportable event: from: death.To: serious injury.Corrected section h6 type of investigation: from: 3331 and 4114.To: 4114.Corrected section h6 investigation findings: from: 4213.To: 213.
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Search Alerts/Recalls
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