Catalog Number 690016 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant investigation.
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Event Description
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The following was reported to the fda on mw5101085: an unspecified white substance or particle was observed in the syringe.Additional information was solicited.
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Event Description
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The following was reported to the fda on mw5101085: an unspecified white substance or paticle was observed in the syringe.Additional information was solicited.See h10 for manufacturing evaluation.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant investigation.Additional information was not provided upon solicitation.The reported event is not confirmed.A review of the batch record was performed.There was no non-conformances or deviations in the manufacturing record.This case will be re-assessed and a supplemental report will be submitted upon receipt of new and relevant information.The reported event will be monitored and trended for analysis.
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Search Alerts/Recalls
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