Model Number N/A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of jufq8517 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (jufq8517) have been reported from the same facility.
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Event Description
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It was reported package found with the prep pad open.No other information was provided.It was reported this occurred on three devices.This report address the second device.
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Event Description
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It was reported package found with the prep pad open.No other information was provided.It was reported this occurred on three devices.This report address the second device.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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Search Alerts/Recalls
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