Model Number 383594 |
Event Date 10/07/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the needle perforating through the catheter.This event occurred four times.The following information was provided by the initial reporter.The customer stated: the catheter has is damage by the point of the needle where it is introduce to the body customer said it had happened 4 times and he has one of the product to return for investigation.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd nexiva¿ diffusics¿ closed iv catheter system, the device experienced the needle perforating through the catheter.This event occurred four times.The following information was provided by the initial reporter.The customer stated: the catheter has is damage by the point of the needle where it is introduce to the body customer said it had happened 4 times and he has one of the product to return for investigation.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-10-18 investigation summary: bd received 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection of the sample, since no defect was observed when the tip of the needle was observed with a microscope.Since the reported failure was not confirmed a root cause related to our manufacturing process cannot be established.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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