Catalog Number 306595 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2024 |
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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"purpose of use: intravenous tube flushing before infusion basis for use:intravenous flushing before infusion port use condition of use:bd pre-flush catheter flushing syringe with cracked wall and fluid leakage adverse event condition:cracked pre-flush syringe impact on victims:possible contamination of the fluid in the pre-flush, use may result in infection of the tubing or body treatment action taken:(b)(6) 2024.Treatment taken:replacement of a pre-flush syringe with a new one time to improvement of adverse event:(b)(6) 2024".
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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 3142709.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 "purpose of use: intravenous tube flushing before infusion basis for use:intravenous flushing before infusion port use condition of use:bd pre-flush catheter flushing syringe with cracked wall and fluid leakage adverse event condition:cracked pre-flush syringe impact on victims:possible contamination of the fluid in the pre-flush, use may result in infection of the tubing or body treatment action taken: (b)(4) 2024 treatment taken:replacement of a pre-flush syringe with a new one time to improvement of adverse event: 2024-01-20".
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Search Alerts/Recalls
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