Catalog Number 306594 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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When the nurse used the irrigator, she noticed that the prefilled line was broken.
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Manufacturer Narrative
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Pr (b)(6) follow up.A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3297914.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h10 narrative.
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Event Description
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Additional information received.When the nurse used the irrigator, she noticed that the prefilled line was broken.1.Can you please get information regarding where the break was? was it the plunger rod? was it the barrel or barrel flange? the plunger rod top.
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Search Alerts/Recalls
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