Catalog Number 682245 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that kinking occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, "we have observed an increasing number of problems with arterial pressure monitoring after cannula exchange.We get worse quality on arterial curve readings.Have to exchange cannula several times because ti does not function.Looks as if the catheter that goes into the artery is kinking at the point between the "house" and the "gliding lock".Looks as if the connection in that area is too weak, we can see the catheter bending and hence the bad quality on the curves.".
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Event Description
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It was reported that kinking occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, "we have observed an increasing number of problems with arterial pressure monitoring after cannula exchange.We get worse quality on arterial curve readings.Have to exchange cannula several times because ti does not function.Looks as if the catheter that goes into the artery is kinking at the point between the "house" and the "gliding lock".Looks as if the connection in that area is too weak, we can see the catheter bending and hence the bad quality on the curves.".
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Manufacturer Narrative
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Investigation summary: a bd quality engineer inspected the returned unit and confirmed the reported observation of a bend in the catheter tubing.The returned sample was tested on flowitch button operation force, and it passed the specification of 2.22 ¿ 22.24n.The floswitch button operation force of the returned sample was within specification and hence the customer¿s experience of ¿kinking at the point between the ¿house¿ and the ¿gliding lock¿ could not be confirmed.A device history record review showed no non-conformance's associated with this issue during the production of this batch.This is the first complaint of this type received for this batch.As a result, a definitive root cause of this issue.Customer complaint trends are evaluated on a monthly basis.
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Search Alerts/Recalls
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