Catalog Number UNKNOWN |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that 2 unspecified bd infusion set had large gaps of air in line.The following information was provided by the initial reporter: it was reported by the customer that there a large gaps of ail during a lipid infusion that moved past the ail sensor without triggering an alarm.
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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.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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).
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Event Description
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It was reported that 2 unspecified bd infusion set had large gaps of air in line.The following information was provided by the initial reporter: it was reported by the customer that there a large gaps of ail during a lipid infusion that moved past the ail sensor without triggering an alarm.
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Manufacturer Narrative
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An air in line complaint was received from the customer.No product or photo was returned by the customer.The customer complaint of air in line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
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Search Alerts/Recalls
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