Model Number 383594 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Pain (1994)
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Event Date 11/24/2021 |
Event Type
malfunction
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Event Description
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It was reported bd nexiva¿ diffusics¿ closed iv catheter system had a catheter tip that was deformed and discolored.The following information was provided by the initial reporter: "diffusics area of fenestrated tip is enlarged/discolored.".
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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 bd nexiva¿ diffusics¿ closed iv catheter system had a catheter tip that was deformed and discolored.The following information was provided by the initial reporter: "diffusics area of fenestrated tip is enlarged/discolored.".
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the 2 opened and 6 unopened samples submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.The samples were compared to the product specifications and were found to be within the spec.The reported discoloration is from the laser used during production.Sometimes there can be some slight burning of the catheter material from the laser, but a small amount is still considered acceptable per manufacturing specifications.The opened samples also underwent our internal penetration testing and showed no irregularities during the test.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
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Search Alerts/Recalls
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