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 04/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported unspecified bd¿ infusion set had backflow issues.The following information was provided by the initial reporter: "rn, stated that yesterday she had a chemotherapy infusion (hanging as a secondary but programmed as a primary in guardrails) that still had drops being pulled from the primary normal saline infusion even though two hangers were used to lower the normal saline.She stated she clamped the normal saline infusion and the chemotherapy infused without issue.".
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Event Description
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It was reported unspecified bd¿ infusion set had backflow issues.The following information was provided by the initial reporter: "rn, stated that yesterday she had a chemotherapy infusion (hanging as a secondary but programmed as a primary in guardrails) that still had drops being pulled from the primary normal saline infusion even though two hangers were used to lower the normal saline.She stated she clamped the normal saline infusion and the chemotherapy infused without issue.".
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.The customer complaint that the rn stated that yesterday she had a chemotherapy infusion (hanging as a secondary but programmed as a primary in guardrails) that still had drops being pulled from the primary normal saline infusion even though two hangers were used to lower the normal saline 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.
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Search Alerts/Recalls
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