Model Number 381834 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Event Description
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It was reported that 2 bd insyte¿ autoguard¿ shielded iv catheters had defective adapters that weren't able to connect to their mating components.The following information was provided by the initial reporter: "one of our officers has reported an issue with the 20g cannula.States that the end where the cannula attaches to the bung was faulty and unable to attach it.Said that this has occurred twice.We were unable to attach 2 separate bungs as they were able to be screwed on but wouldn't secure.It appears that possibly the thread was missing?".
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
|
It was reported that 2 bd insyte¿ autoguard¿ shielded iv catheters had defective adapters that weren't able to connect to their mating components.The following information was provided by the initial reporter: "one of our officers has reported an issue with the 20g cannula.States that the end where the cannula attaches to the bung was faulty and unable to attach it.Said that this has occurred twice.We were unable to attach 2 separate bungs as they were able to be screwed on but wouldn't secure.It appears that possibly the thread was missing?".
|
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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