Catalog Number H938739 |
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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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 dust was observed inside an unspecified quantity of exactamix 1000 ml eva (ethylene vinyl acetate) tpn (total parenteral nutrition) bags.These were observed during setup, prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the actual devices were not available; however, a photograph of the shipping box was provided for evaluation.Visual inspection of the photograph could not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.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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