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 Type
malfunction
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Manufacturer Narrative
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B3: event date: within the last month of (b)(6) 2024.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 contaminants were discovered on an unspecified quantity of automated compounding device disposables.The contaminants were described as ¿particles¿.The particles were all discovered before leaving the pharmacy prior to patient use.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 h6 and h10: h10: the devices were not returned, and the lot number is unknown; 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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