Model Number MZ5301 |
Device Problems
Complete Blockage (1094); Restricted Flow rate (1248)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the minibore pressure rated ext, iv connector was blocked/occluded and couldn't apply fluids.This occurred 50 separate times during use.The following information was provided by the initial reporter: "customer wasn't able to applied fluids over connector.After disconnecting infusion was possible.".
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Manufacturer Narrative
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H6: investigation summary two mz5301 samples from lot 19116785 were received for investigation; one inside its sealed packaging and in opened packaging.A visual inspection did not identify signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by separately connecting each sample to a bd luer slip syringe and a bd 50ml plastipak syringe from retained stock and flushing with fluid; flow restriction or complete occlusion was not identified during testing.Furthermore, pressure fluid was applied from the male luer component; no leakage or issues were identified during pressure testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19116785 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz5301 product in the past 12 months.
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Event Description
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It was reported that the minibore pressure rated ext, iv connector was blocked/occluded and couldn't apply fluids.This occurred 50 separate times during use.The following information was provided by the initial reporter: "customer wasn't able to apple fluids over connector.After disconnecting infusion was possible.".
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Search Alerts/Recalls
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