Catalog Number 383642 |
Device Problems
Difficult to Remove (1528); Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/28/2022 |
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 safety mechanism failed to disengage while using the bd nexiva¿ closed iv cannula system.This event occurred 3 times.The following information was provided by the initial reporter: 3 cases of needle getting stuck in needle safety device and unable to be disconnected from the cannula.
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Event Description
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It was reported that the safety mechanism failed to disengage while using the bd nexiva¿ closed iv cannula system.This event occurred 3 times.The following information was provided by the initial reporter: 3 cases of needle getting stuck in needle safety device and unable to be disconnected from the cannula.
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Manufacturer Narrative
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Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displays a used 22gx1.00in single port nexiva device fully retracted and not decoupled from the wing adapter.The photo shows the device inserted in the patient's arm and the blood in the catheter extension.The reported issue was confirmed as the device failed to decouple.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Search Alerts/Recalls
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