Catalog Number 2B8071 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Event Description
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It was reported that a vial-mate reconstitution device had particulate matter within it.After the vial (non-baxter product) was attached to the sodium chloride solution bag with the vial-mate device a dark grey particulate was observed in the solution bag.The customer stated that the particulate matter was the membrane of the vial.The customer stated that they previously used filters to prevent this from occurring but have since discontinued filter use.This occurred during use.There was no patient injury, medical intervention or adverse event associated with this event.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device has been received by baxter and is currently under evaluation.Upon completion of the device evaluation, or if additional relevant information is obtained, then a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This lot was manufactured from 09/20/2013 ¿ 09/24/2013.Evaluation: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.Visual inspection showed no defects.The device was connected to a solution bag and vial for functional testing with no particulate matter observed.The reported problem was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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