Model Number 129416M |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the user experienced issues with placement of the catheters on two occasions where they did not work appropriately; both catheters did not drain after placement resulting in replacement.The patient had three affected trays that were used in cvicu and cicu.Per follow up via email on 16feb21, there were three additional temperature sensing trays affected for a total six from bmcs.
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Event Description
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It was reported that the user experienced issues with placement of the catheters on two occasions where they did not work appropriately; both catheters did not drain after placement resulting in replacement.The patient had three affected trays that were used in cvicu and cicu.Per follow up via email on 16feb21, there were three additional temperature sensing trays affected for a total six from bmcs.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A dhr review is not required as the event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was evaluated.
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Search Alerts/Recalls
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