Catalog Number 270400 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).
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Event Description
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It was reported that the chloraprep applicator did not have any solution after breaking the ampoule and applying to patient's skin.
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Event Description
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It was reported that the chloraprep applicator did not have any solution after breaking the ampoule and applying to patient's skin.
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Manufacturer Narrative
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A photo has been provided for evaluation.This photo unfortunately does not provided any evidence to perform an investigation as it only shows the outer carton packaging and not the product affected.As a result, this failure mode could not be verified and a root cause could not be defined at this time.Production record review could not be completed as no lot information were provided.No previous complaint from the same product code and lot (unk) related to complaint code ¿solution dried / missing / not enough¿ have been received from august 2018 to august 2020.No adverse trend observed, defect is within control limits.No further actions required at this time.This failure mode will continue to be tracked and trended h3 other text : see narrative below.
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Search Alerts/Recalls
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