Model Number 381423 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: iv catheter needle would not retract into safety spring.The nurse inserted the iv, manually pulled the needle from the insertion site.Once the iv site was secured, the nurse tried to push the safety button to retract the needle but it did not work.
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances 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
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter experienced a needle that would not retract.The following information was provided by the initial reporter: iv catheter needle would not retract into safety spring.The nurse inserted the iv, manually pulled the needle from the insertion site.Once the iv site was secured, the nurse tried to push the safety button to retract the needle but it did not work.
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Search Alerts/Recalls
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