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Model Number 21-2767-24 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that the continuous infusion pump was installed in a port-a-cath catheter via a hubber needle.At the end of the chemotherapy content, extravasation from the needle was noticed.The issue was found during use with a patient, but no patient injury was identified.
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Manufacturer Narrative
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Date of event, is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Manufacturer Narrative
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Health impact, and evaluation codes: updated.No product was returned therefore no device analysis could be completed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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