Model Number 383517 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that 3 bd nexiva¿ closed iv catheter systems experienced catheter damage.The following information was provided by the initial reporter: the head nurse of ct room reported that there were burrs when she opened the package.
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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 3 bd nexiva¿ closed iv catheter systems experienced catheter damage.The following information was provided by the initial reporter: the head nurse of ct room reported that there were burrs when she opened the package.
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Manufacturer Narrative
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Investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photo of a 20 ga x 1.25in nexiva single port.A visual inspection of the photo discovered some flash on the catheter tip.The reported issue was confirmed.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.This may originate during the manufacturing process due to alignment of the set together station, bent tubing, or air blow inconsistency.There is a 100% vision system inspection and a sampling plan implemented for lie distance, which mitigates the occurrence of this defect.This defect is also common during tip adhesion break during use.Without the physical device to perform further testing the cause is undetermined.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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