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Catalog Number 306595 |
Device Problems
Fracture (1260); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
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 becomes available.Device problem code: a040101 - fracture patient problem code: f26 ¿ no health consequences or impact the actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
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Event Description
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At 10:33 on (b)(6) 2023, when the responsible nurse was performing infusion treatment for the patient, because the patient had an infusion port, a pre-flush was used to flush the tube.After activating the pre-flush, a crack in the tube wall was found.If there is a trace, and a little solution seeps out from the crack, replace it immediately.If there is no such phenomenon, report it to the head nurse immediately and report the adverse event of the device.
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Event Description
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No additional information received.At 10:33 on (b)(6) 2023, when the responsible nurse was performing infusion treatment for the patient, because the patient had an infusion port, a pre-flush was used to flush the tube.After activating the pre-flush, a crack in the tube wall was found.If there is a trace, and a little solution seeps out from the crack, replace it immediately.If there is no such phenomenon, report it to the head nurse immediately and report the adverse event of the device.
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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 306595 and lot number 2306135.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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Search Alerts/Recalls
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