Model Number MZ1000-07 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Underdose (2542)
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Event Date 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: used 2.5ml covidien monoject syringe, lot: 19i1124, exp: 2021-08-31, 0.9% sodium chloride; non-bd extension set; td (b)(6) 2020.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
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Event Description
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It was reported that there was a leak between the maxzero and a non-bd syringe.The event occurred in the cvicu.It was reported that patient did not receive the full dose of antibiotic as a result.There was no patient or user harm.The event did not cause a delay that significantly impacted patient outcome.Although requested, no patient information provided.
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Event Description
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It was reported that there was a leak between the maxzero and a non-bd syringe.The event occurred in the cvicu.It was reported that patient did not receive the full dose of antibiotic as a result.There was no patient or user harm.The event did not cause a delay that significantly impacted patient outcome.Although requested, no patient information provided.
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Manufacturer Narrative
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The customer¿s report of leak at connection between the maxzero and a non-bd syringe was not confirmed.All of the components were inspected under a microscope for any cracks, fractures, or stress marks.No anomalies were observed on the set during visual inspection.Functional testing showed no anomalies.The received component and female/male luer ports from the extension set were measured and were within iso standards.The root cause of the customer's report was not identified.
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Search Alerts/Recalls
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