Catalog Number 383518 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd nexiva single port tubing ruptured.The following information was provided by the initial reporter: nexiva split vertically down the extension upon contrast injection.(b)(6) 2024 1.Is there any erroneous results/exposure to bodily fluid no exposure to bodily fluids.This was a newly inserted nexiva, placed by our vat immediately prior to administration of contrast.Brisk blood return at time of insertion as well as prior to contrast injection was noted & documented.2.Kindly confirm if any needle/probe stick injury /safety issue reported.No needle stick injury.Only safety issue is the potential for contrast extravasation or infusion of air via split in tubing.
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Event Description
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No additional information.
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Manufacturer Narrative
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Investigation results: the complaint of a split in the extension tubing was confirmed from the two photographs that were provided for investigation.The photos showed a 20g nexiva unit with a longitudinal split in the extension tubing.The split and evidence of use were consistent with a rupture due to overpressurization.The instructions for use (ifu) provide instructions, warnings, and settings for power injection equipment to prevent catheter failure.Based on the reported event and the condition of the sample, the damage likely occurred during use.No defects associated with the manufacturing process could be confirmed from the photo; however, without the physical sample, the root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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