Catalog Number JC7751 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that a y-type blood/soln set leaked blood at the port (spike) that was not being used even when the roller clamp was fully engaged.This was discovered during an unspecified process step.The second spike port of the set that went into the unit of red blood cells (rbcs) had no issues.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H11: correcting the following fields to align with the product reported in d4: d4: model #, d4: expiration date, d4: unique identifier (udi) #, g4: combination product.The d4: unique device identifier (udi) # is for the product reported in d4.This product code is sold/distributed outside the us, but is deemed same as or similar to product distributed in the us.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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