Catalog Number 306595 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
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.
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Event Description
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The patient received infusion treatment for malignant tumors at 14:35.After the infusion, the picc catheter was sealed, and the core rod prolapsed when using the prefilled catheter irrigator.This glitch affects patients the picc tube was flushed.The responsible nurse replaced the new prefilled catheter irrigator and successfully flushed the patient's picc tube without causing any harm to the patient.
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Event Description
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No additional information received.The patient received infusion treatment for malignant tumors at 14:35.After the infusion, the picc catheter was sealed, and the core rod prolapsed when using the prefilled catheter irrigator.This glitch affects patients the picc tube was flushed.The responsible nurse replaced the new prefilled catheter irrigator and successfully flushed the patient's picc tube without causing any harm 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 3173835.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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