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Catalog Number 306595 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
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Event Description
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The nurse in the neurosurgery ward was preparing to seal the patient's tube, took out the prefilled catheter irrigator, and found that there was leakage in the tube wall.After inspection, it was found that there was a crack in the tube wall causing leakage, so she immediately discarded it and replaced the prefilled catheter irrigator to complete the operation.
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Event Description
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No additional information received.The nurse in the neurosurgery ward was preparing to seal the patient's tube, took out the prefilled catheter irrigator, and found that there was leakage in the tube wall.After inspection, it was found that there was a crack in the tube wall causing leakage, so she immediately discarded it and replaced the prefilled catheter irrigator to complete the operation.
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Manufacturer Narrative
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(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 3233687.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.
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Search Alerts/Recalls
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