Catalog Number 2C4041 |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medwatch report number: (b)(4).Device manufacturer address 1: (b)(4).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 there was backflow while using a y-type tur/bladder irrigation set.It was further reported that a continuous bladder irrigation bag was infused into the bladder despite the tubing being clamped.This issue was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Addition information was added to h4 and h6.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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