Catalog Number 2J8002 |
Device Problems
Leak/Splash (1354); Cut In Material (2454)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was received and is currently awaiting evaluation.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 intravia container was leaking from a cut in the bag seam near the port.The reporter stated that the bag was filled with sufentanil.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed and noted a corner of the intravia bag cut off and port tubing positioned outside of applicable tolerances.Pressure leak test was performed and noted a leak from the port seal.The reported condition was verified and the cause is unknown.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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