Catalog Number 2R8858 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that a clearlink paclitaxel set was leaking from the junction of the white tape marker area on the tubing where it is inserted into pump.The reporter did not know whether the tubing had been placed in the unspecified pump at the time of the event.This occurred during an unspecified process step.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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Device manufacturer address 1: (b)(4).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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