Catalog Number 2B8071 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/08/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Visual inspection was performed with no issues noted with the vial-mate; however, the device was docked to the incorrect port on the solution bag.The reported condition was unable to be replicated; however, connection of the vial-mate to an incorrect port on the bag was discovered and is a known cause of leakage.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).This lot was manufactured may 9th, 2014 - may 13th, 2014.Evaluation summary: the device was returned for evaluation connected to a port of an empty solution bag and a drug vial.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Simulated use testing was performed by docking the device to an in-house solution bag and the returned drug vial.Activation and mixing were performed with no issues or leaks noted.The device was found to operate per specification.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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Manufacturer Narrative
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(b)(4).The device has been received and the evaluation is in progress.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.
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Event Description
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It was reported that a vial-mate reconstitution device leaked from ¿around the blue piece of the adapter¿, at the interface with a viaflex container (baxter product).This occurred as a nurse was performing reconstitution with 3.375 g of a non-baxter drug and before patient connection.This occurred immediately after admixture.The reporter stated that the vial-mate was securely attached to both the bag and vial.The needle was visibly penetrating the stopper and the vial-mate was fully activated.No irregularities were noticed with the vial-mate or its packaging.There was no patient involvement.No additional information is available.This is report 2 of 2.
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Search Alerts/Recalls
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