Catalog Number 306594 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2023 |
Event Type
malfunction
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Event Description
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At 09:30 a.M.On (b)(6) 2023, before giving fluids to, he found that the needle bolt had fallen off and was not connected to the piston when he took out the catheter to flush the 24-bed child.
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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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Manufacturer Narrative
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Pr 9487141 follow up.A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3132167.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.At 09:30 a.M.On 2023 (b)(6) , before giving fluids to, he found that the needle bolt had fallen off and was not connected to the piston when he took out the catheter to flush the 24-bed child.
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Search Alerts/Recalls
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