Model Number 8884720221 |
Device Problem
Material Rupture (1546)
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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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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported the item burst without warning.Additional information received on 16mar2023 stated it failed by the balloon that is designed to hold the tube against the stomach wall to keep it tight preventing leakage.It burst without warning.Necessitating a call to 911 to be taken to the er.No additional information has been provided.
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Manufacturer Narrative
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Updated section b5 to remove the mentioning of 911 and the trip to the er.Per additional information received this event did not result in a call to 911 or a trip to the er.Instead, the device burst without warning when the doctor tried to insert it.
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Event Description
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The customer reported the item burst without warning.Additional information received on 16mar2023 stated it failed by the balloon that is designed to hold the tube against the stomach wall to keep it tight preventing leakage.Additional information received on 27mar2023 stated that it burst without warning when the doctor tried to insert it.
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Manufacturer Narrative
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A sample was not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.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.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.The production personnel received awareness of this complaint.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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Search Alerts/Recalls
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