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 03/15/2024 |
Event Type
malfunction
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Event Description
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Prior to patient infusion, when a pre-filled catheter flusher is used to flush the tube to return blood, it pushes the mandrel and the piston separates from the jacket, resulting in fluid leakage; replace the syringe with a new one and flush the tube for the patient.
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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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Manufacturer Narrative
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Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number (b)(4) and lot number 3178676.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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No additional information received prior to patient infusion, when a pre-filled catheter flusher is used to flush the tube to return blood, it pushes the mandrel and the piston separates from the jacket, resulting in fluid leakage; replace the syringe with a new one and flush the tube for the patient.
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Search Alerts/Recalls
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