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Catalog Number 2C4009K |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 bladder of a large volume folfusor ruptured during filling with cytostatic drug.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added to d4: expiration date, h10.H10: should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: the lot was manufactured between november 21, 2022 ¿ november 22, 2022.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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