Catalog Number EMC9513 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: renal department health park liverpool road.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that an extension set was splitting where "the distal end meets the injectable bung attached to the line".This was observed during infusion with propofol.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Retention samples were visually inspected with no obvious issues detected.The retention samples were also gravity and leak tested with no leak observed.The reported issue was not verified through evaluation of the retention samples.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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