Catalog Number UNKNOWN |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
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.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 the unspecified bd infusion set experienced back flow issue.The following information was provided by the initial reporter: 1 clinician reported a generalized error with a secondary infusion occurring in the past but noted it was ¿hung wrong¿ meaning improper head height differential.It was not further described exactly what the error was.The bd team discussed optimizing secondary infusions and the potential for a back check valve failure on secondary infusions.
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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 that there was a back check valve failure could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
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Event Description
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It was reported that the unspecified bd infusion set experienced back flow issue.The following information was provided by the initial reporter: 1 clinician reported a generalized error with a secondary infusion occurring in the past but noted it was ¿hung wrong¿ meaning improper head height differential.It was not further described exactly what the error was.The bd team discussed optimizing secondary infusions and the potential for a back check valve failure on secondary infusions.
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Search Alerts/Recalls
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