Catalog Number 2N9106 |
Device Problem
Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter phone no.Additional: (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 ink on an unspecified quantity of chemo-aide dispensing pins wiped right off and made a huge mess and made it impossible to read.This was discovered prior to patient use, upon receiving the product.There was no patient involvement.No additional information is available.
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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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