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Catalog Number 2C4041 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that debris was observed in the tubing of three (3) y-type tur/bladder irrigation sets.This was identified after opening the packaging.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: one actual device was received for evaluation; the other two samples were not received and therefore, could not be evaluated.A visual inspection was performed using the naked eye which revealed an intrinsic embedded particle related to the product or raw material.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue.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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