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 12/30/2021 |
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 bd nexiva¿ closed iv catheter system had burrs upon opening the package.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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H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo of a 22 ga x 1.00 in nexiva single port from lot number 1042628.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.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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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system had burrs upon opening the package.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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Search Alerts/Recalls
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