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Model Number 8888145044P |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection noted: the photograph depicts the blue and red ports with a syringe attached to the red port.The yellow caps are on the lumen.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during treatment, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the repair kit, distal connectors were changed and iv antibiotics was given as an intervention.It was stated that catheter was 1 year old.There was no reported patient injury.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during treatment, blood leak was noted coming from the connection of the arterial (red) connector and the extension tube.Then after a few weeks, while checking for permeability of the catheter, the venous (blue) had the same issue.It was stated that the connector was changed with the bard repair kit, distal connectors were changed and iv antibiotics was given as an intervention, chlorhexidine 2% alcohol 70 % was the cleaning agent used and tego adapter was the method used to tighten the adapters.It was stated that there was no significant blood loss due to the event.It was stated that catheter was 1 year old.There was no patient injury.
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Search Alerts/Recalls
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