Model Number 383512 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in the needle was difficult to disengage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: for routine operation, the needle core of the anti-needle indwelling needle cannot be pulled out, and the patient questions the safety of the material.
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Manufacturer Narrative
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H6: 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 while using bd nexiva¿ closed iv catheter system ¿ single port 22 ga 1.00 in the needle was difficult to disengage.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: for routine operation, the needle core of the anti-needle indwelling needle cannot be pulled out, and the patient questions the safety of the material.
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Search Alerts/Recalls
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