Catalog Number 515302 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Chemical Exposure (2570)
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Event Date 04/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd phaseal¿ secondary set c61 leaked.The following information was provided by the initial reporter: in ward, where they are giving cytostatics to patient, they found out a leakage from c61.Leakage came from tube, where it connects to spike.Two patients and a nurse exposed to cytotoxic steam.
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Manufacturer Narrative
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Investigation: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was not provided.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and concentricity of lower part of spike component which caused molding deficit on one side of component.Capa#891423 was initiated.
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Event Description
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It was reported that bd phaseal¿ secondary set c61 leaked.The following information was provided by the initial reporter: in ward, where they are giving cytostatics to patient, they found out a leakage from c61.Leakage came from tube, where it connects to spike.Two patients and a nurse exposed to cytotocsic steam.
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Search Alerts/Recalls
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