Catalog Number 300865 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd plastipak¿ concentric luer lock syringe had pump alarms during the use of the syringe.The following information was provided by the initial reporter: "recurring issues of occlusion alarms and high pressures when used with fresenius syringe pumps.".
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Event Description
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It was reported that bd plastipak¿ concentric luer lock syringe had pump alarms during the use of the syringe.The following information was provided by the initial reporter: "recurring issues of occlusion alarms and high pressures when used with fresenius syringe pumps.".
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Manufacturer Narrative
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H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including force testing and silicone content tests are conducted for each lot.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the available information we are not able to determine a root cause at this time.
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Search Alerts/Recalls
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