Catalog Number 42502E |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set had a hole causing leakage.The following information was provided by the initial reporter: i only know of two sets that had holes in them and i have one of those now that occurred yesterday.There was leakage.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint of defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 42502e lot number 22069211 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Event Description
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It was reported that the bd alaris¿ smartsite¿ gravity set had a hole causing leakage.The following information was provided by the initial reporter: i only know of two sets that had holes in them and i have one of those now that occurred yesterday.There was leakage.
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Search Alerts/Recalls
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