Catalog Number 2C1009K |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bladder of a large volume infusor ruptured; about 50ml of an unknown drug was wasted.This was observed during patient infusion.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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Initial reporter facility name: (b)(6) hospital.Initial reporter address: (b)(6).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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Search Alerts/Recalls
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