Catalog Number 114749 |
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 12/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a particulate matter was observed inside the cap of one unit of revaclear 400.The event occurred before patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.Visual inspection by the naked eye found that the product was wet.It was noted the protection caps were missing.No particulate matter was observed in either of the blood side header caps.A grey longish particulate matter was visible on the dialysate side.The reported condition was verified.Infrared spectroscopy (ir) analysis showed the particulate matter is most likely made of cardboard.Cardboard packaging is not a product used in the cleanroom production of this product.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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