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Catalog Number EMC9608 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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B3: the event occurred on an unspecified date of december 2023, further described as "a week ago".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 a solution administration set was faulty.The white flow rate clamp was not attached to the set and found loose in the packaging.This was observed during preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, three retained samples were evaluated.Visual inspection was performed with special attention given to the tube and the roller clamp and no mis-assembled sets were noted.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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