Catalog Number H938740 |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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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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E1: initial reporter address: (b)(6) 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 unspecified quantity [at least three (3)] of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags broke at the top seam near where the bag would hang from a pole which resulted in a leak.This issue was identified during multiple process steps.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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H10: the devices were discarded; therefore, a device analysis could not be completed.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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