Catalog Number AB-19608-KS |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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During patient use 3 catheters were used before finding one that flow would properly come out.The patient's condition was reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the stimucath catheter with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the stimucath catheter with no relevant findings.Therefore, the potential cause of the distal tip bent could not be determined based upon the information provided and without the sample.
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Event Description
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During patient use 3 catheters were used before finding one that flow would properly come out.The patient's condition was reported as fine.
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Search Alerts/Recalls
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