Model Number 381433 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).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 while using a bd insyte¿ autoguard¿ shielded iv catheter, the needle would not retract.The following information was provided by the initial reporter: needle did not retract when the button was pushed after successful iv start.
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Event Description
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It was reported that while using a bd insyte¿ autoguard¿ shielded iv catheter, the needle would not retract.The following information was provided by the initial reporter: needle did not retract when the button was pushed after successful iv start.
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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-conformances associated with this issue during the production of this batch.H3 other text : see h10.
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Search Alerts/Recalls
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