Catalog Number 394601 |
Device Problems
Leak/Splash (1354); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that leakage occurred with a connecta plus3 white pegs.The following information as provided by the initial reporter, "resistance when connecting the tap.Leakage during when starting the infusion: unevenness of the plastic at the lock, update on march 28, 2019: risk of bleeding to an anemic child, transfused the day before - risk of infection - risk about the treatment that could be diffused in the bed.".
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Event Description
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It was reported that leakage occurred with a connecta plus3 white pegs.The following information as provided by the initial reporter, "resistance when connecting the tap.Leakage during when starting the infusion: unevenness of the plastic at the lock, update om (b)(6) 2019 : risk of bleeding to an anemic child, transufsed the day before - risk of infection - risk about the treatment that could be diffused in the bed.".
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Manufacturer Narrative
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Investigation: bd was unable to verify the reported issues due to the provided picture did not have clear resolution.No objective evidence of this incident was found during the device history record and quality notifications analysis for the claimed lot.Based on investigation results to date, root cause for manufacturing process cannot be determined.
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Search Alerts/Recalls
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