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 02/21/2024 |
Event Type
malfunction
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Event Description
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"instrument use time:(b)(6) 2024, 13:04:05.Purpose of use:sealing catheters for patient infusions.Basis of use:pre-flush catheter flusher.Condition of use:fracture of the end of the pre-flush catheter flusher's injection panel.Adverse event:fracture of the push panel at the end of the pre-flush catheterization device, resulting in inability to push the device.Impact on victims:none.Time to treatment:(b)(6) 2024, 13:05:00.Treatment taken:replacement of pre-flush catheter flushers.Time to improvement of adverse event:(b)(6) 2024, 13:05:15.Combined use:none.Hospital:(b)(6) hospital".
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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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(b)(4).Follow up.A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 3271736.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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Event Description
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No additional information received "instrument use time:(b)(6) 2024 13:04:05.Purpose of use:sealing catheters for patient infusions.Basis of use:pre-flush catheter flusher.Condition of use:fracture of the end of the pre-flush catheter flusher's injection panel.Adverse event:fracture of the push panel at the end of the pre-flush catheterization device, resulting in inability to push the device.Impact on victims:none.Time to treatment:(b)(6) 2024 13:05:00.Treatment taken:replacement of pre-flush catheter flushers.Time to improvement of adverse event:(b)(6) 2024 13:05:15.Combined use:none.Hospital: (b)(6) hospital".
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Search Alerts/Recalls
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