Catalog Number 306595 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Pr 9526667: 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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On (b)(6).2024, for a patient with an indwelling picc catheter, the nurse prepared to flush the catheter with a 10ml prefilled catheter irrigator.When the air is exhausted, the handle and piston are automatically disconnected and a new prefilled catheter irrigator is immediately replaced.Give it to the patient.
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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 2347122.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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Event Description
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No additional information received on january 8, 2024, for a patient with an indwelling picc catheter, the nurse prepared to flush the catheter with a 10ml prefilled catheter irrigator.When the air is exhausted, the handle and piston are automatically disconnected and a new prefilled catheter irrigator is immediately replaced.Give it to the patient.
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Search Alerts/Recalls
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