Catalog Number 306595 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).Investigation summary: a device history record review was completed by our quality engineer team for provided material number and lot number.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.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported bd syringe 10ml saline fill had difficult plunger movement.The following information was provided by the initial reporter, translated from (b)(6): "when the nurse gives the patient intravenous infusion, when the 10ml flush is used to inject pulses to 5ml, the flushing tube cannot be flushed out without the push.".
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).Investigation summary: a device history record review was completed by our quality engineer team for provided material number and lot number.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.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported bd syringe 10ml saline fill had difficult plunger movement.The following information was provided by the initial reporter, translated from (b)(6): "when the nurse gives the patient intravenous infusion, when the 10ml flush is used to inject pulses to 5ml, the flushing tube cannot be flushed out without the push.".
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Search Alerts/Recalls
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