Catalog Number JC-05400-E |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/04/2016 |
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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Reported event: it was reported that the connector loosens time after time at the catheter end.The catheter was replaced.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the snaplock adapter and epidural catheter with no relevant findings.A corrective action is not required at this time as a potential 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 snaplock adapter and epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter disconnecting from the snaplock adapter could not be determined based upon the information provided and without a sample.
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Event Description
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Reported event: it was reported that the connector loosens time after time at the catheter end.The catheter was replaced.The patient's condition was reported as fine.
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Search Alerts/Recalls
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