Catalog Number 306594 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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The patient's infusion was over and his family called for him to pull out the needle.The nurse went to the bedside and tore off the outer packaging of the 5 ml prefilled catheter flusher and found that there was a break at the bottom of the tube wall, which was immediately replaced with another flusher to seal the needle.
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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.H3 other text : see h10 manufacture narrative.
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Event Description
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No additional information received the patient's infusion was over and his family called for him to pull out the needle.The nurse went to the bedside and tore off the outer packaging of the 5 ml prefilled catheter flusher and found that there was a break at the bottom of the tube wall, which was immediately replaced with another flusher to seal the needle.
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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 306594 and lot number 3206755.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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