Model Number 21-7300-24 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
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Event Description
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It was reported product found to contain to inclusions of concern within the cassette.The inclusions look to between the wall of the cassette and the bag.The foreign materials reported were between the wall of the cassette and the bag.No patient injury was reported.
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Manufacturer Narrative
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While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File (b)(4) is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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