Catalog Number 385100 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2020 |
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.(b)(4).
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Event Description
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It was reported that 3 bd q-syte¿ luer access split-septum stand-alone devices experienced discoloration of the device.The following information was provided by the initial reporter: the head nurse found that there was a natural yellowing of the q-syte in the nearest joint¿ s septum and it was not used.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/14/2020.H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one q-syte and one photo displaying two q-syte units with apparent differences in septum color.During the visual examination of the returned unit it was observed that the silicon septum appeared to be yellow.Discoloration of the silicon septum can occur due to raw materials, during the adhesive curing step in manufacturing, or during sterilization, however no quality issues were found.Storage conditions can also contribute to discoloring of the septum.Although the failures stated in the reported issue were confirmed with the unit provided for investigation, bd could not establish a definite root cause.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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Event Description
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It was reported that 3 bd q-syte¿ luer access split-septum stand-alone devices experienced discoloration of the device.The following information was provided by the initial reporter: the head nurse found that there was a natural yellowing of the q-syte in the nearest joint¿ s septum and it was not used.
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Search Alerts/Recalls
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