BAXTER HEALTHCARE CORPORATION EVACUATED CONTAINER; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
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Catalog Number 1A8504 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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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: event date: the events occurred on an unspecified date in (b)(6) 2023, reported as "over this past week." one (1) device was received and is currently awaiting evaluation.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 the plunger of two (2) 1000 ml evacuated containers fell through when spiking and were at the bottom of the bottles.This was discovered set-up and preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection was performed and the stopper was observed pushed through the bottle.The reported condition was verified.The cause of the condition could not be determined.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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